# K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

- Pathway: 510(k) (Special)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Jun 21, 2018 after 266 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: 3 generations back to K855127 (1986). 4 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System, Healthstats International Pte., Ltd. (2006) Summary page 4.

## Most influential descendants
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own
- K250415: G0 Blood Pressure Monitoring System (G0) (2025), 1 descendant of its own

## Indications for use
The BPro® BT Ambulatory Blood Pressure Monitoring 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 BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT 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 BT 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 BT system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. The BPro BT system is intended only for measurement, recording, and display. It makes no diagnosis.

Source page: https://510kreport.com/device/K173028
Methodology: https://510kreport.com/methodology