US Blood Pressure Validated Device Listing (VDL™)

The ultimate judgment regarding whether a BP measurement device meets the requisite VDL Criteria rests with the Independent Review Committee and is not in any way determined or influenced by the AMA. The AMA does not receive funding from any device manufacturer or other third party in relation to the development of the VDL Criteria or VDL process.*

Brands

Device Types

Cuff Sizes

Population

Brand/Device Type Name and Model Number Validation Protocol Cuff SizesPopulations Served

IEM

Home

Tel-O-Graph

GTIN 0404134602101 7

Photograph of Tel-O-Graph

ANSI/AAMI/ISO 81060-2:2013

Extra Large (38-55 cm), Large (32-38 cm), Medium (24-32 cm), and Small (20-24 cm)

General

IEM

Ambulatory

Mobil-O-Graph

GTIN 0404134610010 4

Photograph of Mobil-O-Graph

ANSI/AAMI/ISO 81060-2:2013

Extra Large (38-55 cm), Large (32-38 cm), Medium (24-32 cm), Small (20-24 cm), and XS (14-20 cm)

General

Walgreens

Home

Walgreens Premium Arm Blood Pressure Monitor

WGNBPA-240BT

Photograph of Walgreens Premium Arm Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2:2013

Standard (23-43 cm)

General

BodyTrace

Home

BodyTrace Cellular Blood Pressure Monitor

BT106

Photograph of BodyTrace Cellular Blood Pressure Monitor

ISO 81060-2:2018

Standard (22-42 cm) and Standard (22-45 cm)

General

CareSimple

Home

CareSimple Blood Pressure Monitor

BT106

Photograph of CareSimple Blood Pressure Monitor

ISO 81060-2:2018

Adult (22-42 cm)

General

ForaCare

Home

Fora TN'G BP

P80

Photograph of Fora TN'G BP

ANSI/AAMI/ISO 81060-2: 2013

Standard (24-43 cm)

General

Smart Meter

Home

iBloodPressure

SMBP802-GS-001

Photograph of iBloodPressure

ANSI/AAMI/ISO 81060-2:2009

Standard (22-42 cm)

General

Greater Goods

Home

Greater Goods BP

0040, 0604, 0664

Photograph of Greater Goods BP

ISO 81060-2:2018

Standard (22-42 cm)

General

BodyTrace

Home

Blood Pressure Monitor

BT105

Photograph of Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2:2013

Adult (22-32 cm) and Extended (22-42 cm)

General

CareSimple

Home

Blood Pressure Monitor

BT105

Photograph of Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2:2013

Adult (22-32 cm) and Extended (22-42 cm)

General

Transtek

Home

Transtek Blood Pressure Monitor

LS802-GS

Photograph of Transtek Blood Pressure Monitor

ISO 81060-2:2018

Extra Large (22-45 cm), Large (22-42 cm), and Standard (22-32cm)

General

Transtek

Home

Transtek Blood Pressure Monitor

LS802-GP

Photograph of Transtek Blood Pressure Monitor

ISO 81060-2:2018

Extra Large (22-45 cm), Large (22-42 cm), and Standard (22-32cm)

General

Omron

Home

Automatic Upper Arm Blood Pressure Monitor

HEM-9210T

Photograph of Automatic Upper Arm Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2:2009

Extra Large (42-50 cm), Small (17-22 cm), and Wide Range (22-42 cm)

General

Omron

Home

Blood Pressure Monitor

HEM-9200T

Photograph of Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2:2009

Adult (22-42 cm)

General

Withings

Home

Withings BPM Connect

WPM05

Photograph of Withings BPM Connect

ANSI/AAMI/ISO81060-2:2013

Integrated (22-42 cm)

General

Microlife

Home

WatchBP Home A BT

BP3MX1-3C

Photograph of WatchBP Home A BT

BHS Revised Protocol: 1993

Large (32-42 cm), Small (14-22 cm), and Standard (22-32cm)

General

Microlife

Home

WatchBP Home A

BP3MX1-3

Photograph of WatchBP Home A

BHS Revised Protocol: 1993

Large (32-42 cm), Small (14-22 cm), and Standard (22-32cm)

General

Microlife

Home

WatchBP Home N

BP3MX1-4

Photograph of WatchBP Home N

BHS Revised Protocol: 1993

Large (32-42 cm), Small (14-22 cm), and Standard (22-42 cm)

General

Microlife

Home

WatchBP Home

BP3MX1-1

Photograph of WatchBP Home

BHS Revised Protocol: 1993

Large (32-42 cm), Small (14-22 cm), and Standard (22-32cm)

General

Omron

Home

Evolv® Wireless Upper Arm Blood Pressure Monitor

BP7000

Photograph of Evolv® Wireless Upper Arm Blood Pressure Monitor

ANSI/AAMI/ISO 81060-2: 2013

Adult (22-42 cm)

General

SunTech

Office

CT40 Spot-Check Vital Signs

260

Photograph of CT40 Spot-Check Vital Signs

BHS Revised Protocol: 1993

Adult- 22-33cm, Large – 31-40cm, Large Plus- 40-55cm, Plus- 28-40cm, and Small- 17-25cm

General

Microlife

Office Automated

WatchBP Office ABI

TWIN200 ABI

Photograph of WatchBP Office ABI

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm), Large-Extra Large (32-52 cm), Medium (22-32 cm), and Small (14-22 cm)

General

Microlife

Office Automated

WatchBP Office

BP3SK1-3B

Photograph of WatchBP Office

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm), Large-Extra Large (32-52 cm), Medium (22-32 cm), and Small (14-22 cm)

General

Microlife

Office Automated

WatchBP Office AFIB

TWIN200 AFS

Photograph of WatchBP Office AFIB

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm), Large-Extra Large (32-52 cm), Medium (22-32 cm), and Small (14-22 cm)

General

A&D Medical

Ambulatory

Professional ABPM with Office Mode

TM-2441

Photograph of Professional ABPM with Office Mode

ANSI/AAMI/ISO 81060-2: 2013

Extra Large (36-50 cm), Large (28-38 cm), Medium (20-31 cm), and Small (15-22 cm)

General

PharmaSmart

Kiosk

PS-2000D

PS-2000D

Photograph of PS-2000D

ANSI/AAMI SP10: 2002* *

Single Cuff System

General

PharmaSmart

Kiosk

PS-1000

PS-1000

Photograph of PS-1000

ANSI/AAMI SP10: 2002* *

Single Cuff System

General

PharmaSmart

Kiosk

PS-2000C

PS-2000C

Photograph of PS-2000C

ANSI/AAMI SP10: 2002* *

Single Cuff System

General

PharmaSmart

Kiosk

PS-2000

PS-2000

Photograph of PS-2000

ANSI/AAMI SP10: 2002* *

Single Cuff System

General

A&D Medical

Ambulatory

Professional ABPM

TM-2440

Photograph of Professional ABPM

ANSI/AAMI/ISO 81060-2: 2013

Extra Large (36-50 cm), Large (28-38 cm), Medium (20-31 cm), and Small (15-22 cm)

General

Omron

Home

5 Series® Wireless

BP7250

HEM-7311

Photograph of 5 Series® Wireless

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

5 Series®

BP7200

HEM-7311

Photograph of 5 Series®

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

3 Series®

BP7100

HEM-7311

Photograph of 3 Series®

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Platinum Upper Arm

BP5450

HEM-7311

Photograph of Platinum Upper Arm

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Gold Upper Arm

BP5350

HEM-7311

Photograph of Gold Upper Arm

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

10 Series® Wireless

BP7450

HEM-7320

Photograph of 10 Series® Wireless

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

7 Series® Wireless

BP7350

HEM-7320

Photograph of 7 Series® Wireless

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Bronze Upper Arm

BP5100

HEM-7311

Photograph of Bronze Upper Arm

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Silver Wireless

BP5250

HEM-7320

Photograph of Silver Wireless

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Complete™ Wireless

BP7900

HEM-7311

Photograph of Complete™ Wireless

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

A&D Medical

Home

ULTRACONNECT Wireless Blood Pressure Monitor

UA-1200BLE

Photograph of ULTRACONNECT Wireless Blood Pressure Monitor

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Integrated (22-42 cm)

General

Hillrom-Welch Allyn

Home

Welch Allyn Home® Blood Pressure Monitor, 1700 Series

H-BP100SBP

Photograph of Welch Allyn Home® Blood Pressure Monitor, 1700 Series

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Standard (22-42 cm), XL (40-54 cm), and XS (15-24 cm)

General

Hillrom-Welch Allyn

Office

Welch Allyn® ProBP™ 2000 Digital Blood Pressure Device

ProBP2000

ProBP1400

Photograph of Welch Allyn® ProBP™ 2000 Digital Blood Pressure Device

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (25-34 cm), Adult Long (25-34 cm), Child (15-21 cm), Large Adult (32-43 cm), Large Adult Long (32-43 cm), Small Adult (20-26 cm), and Thigh (40-55 cm)

General

A&D Medical

Home

Talking+ Blood Pressure Monitor

UA-1030T

UA-1020

Photograph of Talking+ Blood Pressure Monitor

Validation Protocol(s): BHS Revised Protocol: 1993 *

Large (31-45 cm), Medium (23-37 cm), Small (16-24 cm), and Smooth Fit (23-37 cm)

General

A&D Medical

Home

Advanced Manual Inflate Blood Pressure Monitor

UA-705

UA-705V, UA-704

Photograph of Advanced Manual Inflate Blood Pressure Monitor

Validation Protocol(s): BHS Revised Protocol: 1993 *

Large (36-45 cm) and Medium (23.8-36 cm)

General

Hillrom-Welch Allyn

Office

Welch Allyn® Connex® ProBP™ 3400 Digital Blood Pressure Device

ProBP3400 - **Under Recall**

Photograph of Welch Allyn® Connex® ProBP™ 3400 Digital Blood Pressure Device

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (25-34 cm), Adult Long (25-34 cm), Child (15-21 cm), Large Adult (32-43 cm), Large Adult Long (32-43 cm), Small Adult (20-26 cm), Small Child (12-16 cm), and Thigh (40-55 cm)

General

Omron

Wrist

BP6350

HEM-6232T

Photograph of BP6350

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP6100

HEM-6181

Photograph of BP6100

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP4350

HEM-6232T

Photograph of BP4350

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP8000-M

HEM-6410T-ZM

Photograph of BP8000-M

ANSI/AAMI/ISO 81060-2: 2013

Wrist (16.0-19.0 cm)

Special Considerations- see note
Note: Additional devices may be added to the VDL in the future through successive application and review processes as more devices are submitted and reviewed by the Independent Review Committee. The listing currently contains devices that measure other biometrics, it is important to note that for those devices, only the BP measurement components have been reviewed for validation. Clinical Disclaimer: Devices on this list for use at home are validated for clinical accuracy for the population tested and may not always provide accurate BP measurements for a specific individual. Whenever practical, patients are encouraged to bring their home BP devices to the physician’s office or some other qualified health care facility for comparison with an accurate device.

Wrist Cuff Device Disclaimer:
Clinical guidelines call for the user of an upper arm blood pressure (BP) measurement device that has been validated for clinical accuracy for self-measured blood pressure (SMBP). However, a validated wrist cuff blood pressure (BP) device may be used in place of an upper arm device for certain clinical indications, specific patient needs, or additional circumstances (eg, upper arm cuff not suitable for patient arm circumference, unavailability of devices with the appropriate small, large or extra large size cuffs, medical conditions where upper arm devices cannot or should not be used).
Proper technique is especially important when using a wrist cuff device to obtain accurate readings. The device must be correctly placed over the radial artery and held at heart level when readings are taken, with limited movement or wrist flexion. *Protocol Disclaimer: Protocol did not require detailed reporting on arm and cuff sizes. Device met all requirements, but it is unclear if valid with larger arm circumferences.

**Welch-Allyn ProBP3400 recall information: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=186903

Submission for Manufacturers

The process for submitting a BP measurement device to be considered for the VDL is easy.

Learn more

US Blood Pressure Validated Device Listing (VDL)

The ultimate judgment regarding whether a BP measurement device meets the requisite VDL Criteria rests with the Independent Review Committee and is not in any way determined or influenced by the AMA. The AMA does not receive funding from any device manufacturer or other third party in relation to the development of the VDL Criteria or VDL process. For more information, visit www.validateBP.org

BP6350BP6100BP4350BP8000-M

Filters applied:

Brand/Device Type Name and Model Number Validation Protocol Cuff SizesPopulations Served

IEM

Home

Tel-O-Graph

GTIN 0404134602101 7

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2013

Extra Large (38-55 cm)

Large (32-38 cm)

Medium (24-32 cm)

Small (20-24 cm)

General

IEM

Ambulatory

Mobil-O-Graph

GTIN 0404134610010 4

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2013

Extra Large (38-55 cm)

Large (32-38 cm)

Medium (24-32 cm)

Small (20-24 cm)

XS (14-20 cm)

General

Walgreens

Home

Walgreens Premium Arm Blood Pressure Monitor

WGNBPA-240BT

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2013

Standard (23-43 cm)

General

BodyTrace

Home

BodyTrace Cellular Blood Pressure Monitor

BT106

Photograph of device_name

ISO 81060-2:2018

Standard (22-42 cm)

Standard (22-45 cm)

General

CareSimple

Home

CareSimple Blood Pressure Monitor

BT106

Photograph of device_name

ISO 81060-2:2018

Adult (22-42 cm)

General

ForaCare

Home

Fora TN'G BP

P80

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Standard (24-43 cm)

General

Smart Meter

Home

iBloodPressure

SMBP802-GS-001

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2009

Standard (22-42 cm)

General

Greater Goods

Home

Greater Goods BP

0040, 0604, 0664

Photograph of device_name

ISO 81060-2:2018

Standard (22-42 cm)

General

BodyTrace

Home

Blood Pressure Monitor

BT105

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2013

Adult (22-32 cm)

Extended (22-42 cm)

General

CareSimple

Home

Blood Pressure Monitor

BT105

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2013

Adult (22-32 cm)

Extended (22-42 cm)

General

Transtek

Home

Transtek Blood Pressure Monitor

LS802-GS

Photograph of device_name

ISO 81060-2:2018

Extra Large (22-45 cm)

Large (22-42 cm)

Standard (22-32cm)

General

Transtek

Home

Transtek Blood Pressure Monitor

LS802-GP

Photograph of device_name

ISO 81060-2:2018

Extra Large (22-45 cm)

Large (22-42 cm)

Standard (22-32cm)

General

Omron

Home

Automatic Upper Arm Blood Pressure Monitor

HEM-9210T

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2009

Extra Large (42-50 cm)

Small (17-22 cm)

Wide Range (22-42 cm)

General

Omron

Home

Blood Pressure Monitor

HEM-9200T

Photograph of device_name

ANSI/AAMI/ISO 81060-2:2009

Adult (22-42 cm)

General

Withings

Home

Withings BPM Connect

WPM05

Photograph of device_name

ANSI/AAMI/ISO81060-2:2013

Integrated (22-42 cm)

General

Microlife

Home

WatchBP Home A BT

BP3MX1-3C

Photograph of device_name

BHS Revised Protocol: 1993

Large (32-42 cm)

Small (14-22 cm)

Standard (22-32cm)

General

Microlife

Home

WatchBP Home A

BP3MX1-3

Photograph of device_name

BHS Revised Protocol: 1993

Large (32-42 cm)

Small (14-22 cm)

Standard (22-32cm)

General

Microlife

Home

WatchBP Home N

BP3MX1-4

Photograph of device_name

BHS Revised Protocol: 1993

Large (32-42 cm)

Small (14-22 cm)

Standard (22-42 cm)

General

Microlife

Home

WatchBP Home

BP3MX1-1

Photograph of device_name

BHS Revised Protocol: 1993

Large (32-42 cm)

Small (14-22 cm)

Standard (22-32cm)

General

Omron

Home

Evolv® Wireless Upper Arm Blood Pressure Monitor

BP7000

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Adult (22-42 cm)

General

SunTech

Office

CT40 Spot-Check Vital Signs

260

Photograph of device_name

BHS Revised Protocol: 1993

Adult- 22-33cm

Large – 31-40cm

Large Plus- 40-55cm

Plus- 28-40cm

Small- 17-25cm

General

Microlife

Office Automated

WatchBP Office ABI

TWIN200 ABI

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm)

Large-Extra Large (32-52 cm)

Medium (22-32 cm)

Small (14-22 cm)

General

Microlife

Office Automated

WatchBP Office

BP3SK1-3B

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm)

Large-Extra Large (32-52 cm)

Medium (22-32 cm)

Small (14-22 cm)

General

Microlife

Office Automated

WatchBP Office AFIB

TWIN200 AFS

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Large (32-42 cm)

Large-Extra Large (32-52 cm)

Medium (22-32 cm)

Small (14-22 cm)

General

A&D Medical

Ambulatory

Professional ABPM with Office Mode

TM-2441

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Extra Large (36-50 cm)

Large (28-38 cm)

Medium (20-31 cm)

Small (15-22 cm)

General

PharmaSmart

Kiosk

PS-2000D

PS-2000D

Photograph of device_name

ANSI/AAMI SP10: 2002*

Single Cuff System

General

PharmaSmart

Kiosk

PS-1000

PS-1000

Photograph of device_name

ANSI/AAMI SP10: 2002*

Single Cuff System

General

PharmaSmart

Kiosk

PS-2000C

PS-2000C

Photograph of device_name

ANSI/AAMI SP10: 2002*

Single Cuff System

General

PharmaSmart

Kiosk

PS-2000

PS-2000

Photograph of device_name

ANSI/AAMI SP10: 2002*

Single Cuff System

General

A&D Medical

Ambulatory

Professional ABPM

TM-2440

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Extra Large (36-50 cm)

Large (28-38 cm)

Medium (20-31 cm)

Small (15-22 cm)

General

Omron

Home

5 Series® Wireless

BP7250

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

5 Series®

BP7200

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

3 Series®

BP7100

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Platinum Upper Arm

BP5450

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Gold Upper Arm

BP5350

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

10 Series® Wireless

BP7450

HEM-7320

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

7 Series® Wireless

BP7350

HEM-7320

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Bronze Upper Arm

BP5100

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Silver Wireless

BP5250

HEM-7320

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

Omron

Home

Complete™ Wireless

BP7900

HEM-7311

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (22-42 cm)

General

A&D Medical

Home

ULTRACONNECT Wireless Blood Pressure Monitor

UA-1200BLE

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Integrated (22-42 cm)

General

Hillrom-Welch Allyn

Home

Welch Allyn Home® Blood Pressure Monitor, 1700 Series

H-BP100SBP

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Standard (22-42 cm)

XL (40-54 cm)

XS (15-24 cm)

General

Hillrom-Welch Allyn

Office

Welch Allyn® ProBP™ 2000 Digital Blood Pressure Device

ProBP2000

ProBP1400

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (25-34 cm)

Adult Long (25-34 cm)

Child (15-21 cm)

Large Adult (32-43 cm)

Large Adult Long (32-43 cm)

Small Adult (20-26 cm)

Thigh (40-55 cm)

General

A&D Medical

Home

Talking+ Blood Pressure Monitor

UA-1030T

UA-1020

Photograph of device_name

Validation Protocol(s): BHS Revised Protocol: 1993

Large (31-45 cm)

Medium (23-37 cm)

Small (16-24 cm)

Smooth Fit (23-37 cm)

General

A&D Medical

Home

Advanced Manual Inflate Blood Pressure Monitor

UA-705

UA-705V, UA-704

Photograph of device_name

Validation Protocol(s): BHS Revised Protocol: 1993

Large (36-45 cm)

Medium (23.8-36 cm)

General

Hillrom-Welch Allyn

Office

Welch Allyn® Connex® ProBP™ 3400 Digital Blood Pressure Device

ProBP3400 - **Under Recall**

Photograph of device_name

Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

Adult (25-34 cm)

Adult Long (25-34 cm)

Child (15-21 cm)

Large Adult (32-43 cm)

Large Adult Long (32-43 cm)

Small Adult (20-26 cm)

Small Child (12-16 cm)

Thigh (40-55 cm)

General

Omron

Wrist

BP6350

HEM-6232T

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP6100

HEM-6181

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP4350

HEM-6232T

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Wrist (13.5-21.5 cm)

Special Considerations- see note

Omron

Wrist

BP8000-M

HEM-6410T-ZM

Photograph of device_name

ANSI/AAMI/ISO 81060-2: 2013

Wrist (16.0-19.0 cm)

Special Considerations- see note
Note:Additional devices may be added to the VDL in the future through successive application and review processes as more devices are submitted and reviewed by the Independent Review Committee. The listing currently contains devices that measure other biometrics, it is important to note that for those devices, only the BP measurement components have been reviewed for validation. Clinical Disclaimer: Devices on this list for use at home are validated for clinical accuracy for the population tested and may not always provide accurate BP measurements for a specific individual. Whenever practical, patients are encouraged to bring their home BP devices to the physician’s office or some other qualified health care facility for comparison with an accurate device.

Wrist Cuff Device Disclaimer:
Clinical guidelines call for the user of an upper arm blood pressure (BP) measurement device that has been validated for clinical accuracy for self-measured blood pressure (SMBP). However, a validated wrist cuff blood pressure (BP) device may be used in place of an upper arm device for certain clinical indications, specific patient needs, or additional circumstances (eg, upper arm cuff not suitable for patient arm circumference, unavailability of devices with the appropriate small, large or extra large size cuffs, medical conditions where upper arm devices cannot or should not be used).
Proper technique is especially important when using a wrist cuff device to obtain accurate readings. The device must be correctly placed over the radial artery and held at heart level when readings are taken, with limited movement or wrist flexion. *Protocol Disclaimer: Protocol did not require detailed reporting on arm and cuff sizes. Device met all requirements, but it is unclear if valid with larger arm circumferences.

**Welch-Allyn ProBP3400 recall information: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=186903
*The American Medical Association (“AMA”) does not receive funding from any third-party in relation to the development of the Validated Device Listing Criteria (“VDL™ Criteria”), and does not receive funding from any blood pressure (“BP”) device manufacturer or other third-party in relation to the development of the VDL process. No recommendation, promotion, or endorsement is implied or intended by the AMA (or any of the AMA’s affiliated or partner organizations) of any third-party organization, product, device, policy, or service. BP measurement devices are selected to appear on the VDL through an independent review process that determines which available BP measurement devices meet established VDL Criteria for the validation of clinical accuracy. An Independent Review Committee, composed of members who are experts in the BP field, assess whether a BP measurement device satisfies the VDL Criteria. The ultimate judgment regarding whether a BP measurement device meets the requisite VDL Criteria rests with the Independent Review Committee, and is not in any way determined or influenced by the AMA.