BPro BT Radial Pulse Wave Acquisition Device

BPro BT is a wrist-mounted ambulatory blood pressure monitor that measures the radial artery pulse using tonometry. It is intended for adults aged eighteen or older with a palpable radial…

Registry build 21.09.26

BPro BT is a wrist-mounted ambulatory blood pressure monitor that measures the radial artery pulse using tonometry. It is intended for adults aged eighteen or older with a palpable radial pulse and provides measurements for review by qualified medical personnel.

A pressure transducer positioned over the radial artery captures the pulse waveform. Before each monitoring session, the device must be calibrated with the BPCalibrator MC3100+ oscillometric monitor. It can then record systolic pressure, diastolic pressure and pulse rate over twenty-four hours.

Listed Item

The BPro® BT is used to capture the pulse wave from the radial artery.

Data and Power

Bluetooth transfers measurements to BProSoft BT software on a computer for storage, display and reporting. The wrist unit uses a rechargeable lithium-ion battery and a color display. The system measures and records data; clinical interpretation remains with medical personnel.

98manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXN
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Taizhou Rich Medical Products Co., Ltd. Taizhou Jiangsu Contract manufacturer 20
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 7
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shenzhen Brav Electronic Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive

Record

Regulatory record for BPro BT Radial Pulse Wave Acquisition Device
Listed by Healthstats International Pte., Ltd., United States
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
510(k) K173028
Record published 2018-08-14
Record revised 2025-12-31 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for BPro BT Radial Pulse Wave Acquisition Device
Catalogue number Size Status
T6200 series Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baum W.A. Baum Co., Inc. 116
Alphamed Shenzhen Urion Technology Co., Ltd. 68
Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co., Ltd. 59
Arm Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd. 58
A&D Medical A&D Company, Ltd. 56
Diagnostix™ American Diagnostic Corp. 54
Lutech Lutech Industries 51
Veridian Veridian Healthcare 50
Hopkins Medical Products® Hopkins Uniform Company 49
Welch Allyn, Inc. Welch Allyn, Inc. 49
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 48
SunTech Suntech Medical, Inc. 46

Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K173028 2018-06-21
K131916 2014-03-11
K131788 2014-03-04
K101002 2010-06-08
K072593 2007-11-15
K060315 2006-04-07
K051546 2005-06-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer