# K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Apr 7, 2006 after 58 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K855127 (1986). 3 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900247: CBM-3000/CBM-2000/CBM-7000 Blood Pressure System, Colin Medical Instruments Corp. (1990) Summary page 1.
- K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202, Spacelabs, Inc. (1986) Summary page 1.
- K031479: Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Most influential descendants
- K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (2018), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (2007), 4 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own

## Indications for use
The BPro® system is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro wrist-mounted tonometric monitor, a BPCalibrator MC3000 oscillometric blood pressure monitor for calibration, and BProSoft software, a PC-based computer program. Before each measurement session, the wrist device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure and pulse rate over a period of 24 hours. BProSoft PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 24-hour period. The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. The BPro system is intended only for measurement, recording, and display. It makes no diagnosis. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

Source page: https://510kreport.com/device/K060315
Methodology: https://510kreport.com/methodology