# K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Jun 8, 2010 after 57 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: 5 generations back to K872291 (1987). 20 ancestors in all.
2 later devices descend from it; 2 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)
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software, Healthstats International Pte., Ltd. (2007) Summary page 1.
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System, Healthstats International Pte., Ltd. (2006) Summary page 1.
- K051546: Bpcalibrator MC3000/MC3100, Healthstats International Pte., Ltd. (2005) Summary page 1.
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.

## Most influential descendants
- 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-PULSE CASPro/CASPaI Monitors are compact standalone monitors that combine 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 CASProICASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively. The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a non-volatile memory to store and recall measurements. Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment. The A-PULSE CASPro/CASPaI Monitors are intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. 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/K101002
Methodology: https://510kreport.com/methodology