# K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Mar 4, 2014 after 259 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 K872291 (1987). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200, Healthstats International Pte., Ltd. (2010) Summary page 1.
- K040371: A & D Medical UA-767BT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2004) Summary page 1.
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.

## Indications for use
The A-PULSE CASPaI+ Monitor is a compact standalone monitor that combines two methods of blood pressure measurement: * Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and * Radial arterial pulse acquisition via a wrist-mounted tonometer sensor. The A-PULSE CASPaI+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively. The MC3100+ monitor measures systolic and diastolic blood pressure and pulse rate via the oscillometric method via a brachial cuff at the upper arm. The monitors have a non-volatile memory to store and recall measurements, and the ability to transfer measurement data via Bluetooth wireless communications to other suitably equipped electronic devices, such as a PC with Health STATS. my-BP PC software. my-BP PC software is used in conjunction with the HealthSTATS A-PULSE CASPaI+ and MC3100+ Monitors to store and display blood pressure data obtained from the monitors. The A-PULSE CASPaI+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPaI+, have a palpable radial pulse. Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPaI+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K131788
Methodology: https://510kreport.com/methodology