# K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Nov 15, 2007 after 62 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: 4 generations back to K872291 (1987). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 22 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.
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.
- K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI, Omron Healthcare, Inc. (2005) Summary page 1.

## Most influential descendants
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (2010), 2 descendants of its own
- K131916: Bprosoft Casp PC Software (2014), 0 descendants of its own
- K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software (2014), 0 descendants of its own
- K121266: Cardioscope (2012), 0 descendants of its own

## Indications for use
The A-PulseTM Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor. A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery. Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device. A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAI), and a range of other indices. A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

Source page: https://510kreport.com/device/K072593
Methodology: https://510kreport.com/methodology