# K131916: Bprosoft Casp PC Software

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Mar 11, 2014 after 258 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: 6 generations back to K950779 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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 1.
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software, Healthstats International Pte., Ltd. (2007) Summary page 1.
- K110603: Hypertension Management Software Claient Server (HMS-CS), I.E.M. GmbH (2011) Summary page 1.

## Indications for use
The BPro®) system is a noninvasive ambulatory central blood pressure monitoring system based on tonometry at the radial artery of the wrist. The system consists of a BPro® wrist-mounted tonometric monitor, and a BPCalibrator MC3000OM oscillometric blood pressure monitor for calibration, and BProSOft CASPO Software, a PC-based computer program. Before each measurement session, the wrist-mounted tonometric 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, pulse rate, and radial pulse waveform over a 24-hour period. The central aortic systolic pressure (CASP) is calculated utilizing the recorded radial pulse waveform and BProSOft CASPO PC software. BProSOft GASPO 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 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/K131916
Methodology: https://510kreport.com/methodology