BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K173028 ↗

FDA Product Code

DXN

FDA applicant

Healthstats International Pte. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200

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• Bpcalibrator MC3000/MC3100

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• Healthstats Bpro Ambulatory Blood Pressure Monitoring System

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  FDA 510(k) K060315 Active Cleared 7 Apr 2006

• A-Plus Arterial Pulse Waveform Analysis System and Pc Software

  Class II

  FDA 510(k) K072593 Active Cleared 15 Nov 2007

• What is the primary purpose of the BPro BT Ambulatory Blood Pressure Monitoring System, and how does it differ from traditional blood pressure cuffs?

  The BPro BT system is designed for continuous, noninvasive ambulatory blood pressure monitoring by measuring arterial tonometry at the radial artery on the wrist. Unlike traditional cuff-based devices that take intermittent readings, this system provides detailed cardiovascular assessment over extended periods, making it ideal for tracking blood pressure trends outside of a clinical setting. It combines a wrist-mounted monitor with a calibration device (BPCalibrator MC3100+) and software for data analysis, ensuring accuracy through periodic oscillometric validation.

• Is the BPro BT device single-use or reusable, and what maintenance does it require?

  The BPro BT system is reusable and intended for clinical use, meaning it can be used across multiple patients with proper cleaning and maintenance. To ensure accurate readings, it requires regular calibration using the included BPCalibrator MC3100+ device. Additionally, storage conditions must be followed to preserve functionality, as the manufacturer emphasizes proper handling to maintain performance.

• How does the BProSoft BT PC software factor into the device’s functionality, and what role does it play in clinical use?

  The BProSoft BT PC software is a critical component of the system, as it analyzes and visualizes the continuous blood pressure data collected by the wrist-mounted monitor. Clinicians use it to interpret trends, generate reports, and assess cardiovascular health over time. The software integrates with the calibration device to validate measurements, ensuring the data remains reliable for clinical assessment.

• What regulatory pathways has the BPro BT system undergone, and what does that mean for its clinical adoption?

  The BPro BT system has received FDA 510(k) clearance under Special Review and MDR authorization, confirming its compliance with regulatory standards for ambulatory blood pressure monitoring. This means it has been evaluated for safety and effectiveness by the FDA and meets EU medical device regulations, providing confidence in its clinical adoption for noninvasive cardiovascular monitoring in healthcare settings.