# K121266: Cardioscope

- Pathway: 510(k) (Traditional)
- Applicant: Pulsecor Limited
- Decided: Dec 11, 2012 after 229 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). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 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.
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.
- K110603: Hypertension Management Software Claient Server (HMS-CS), I.E.M. GmbH (2011) Summary page 1.

## Indications for use
CardioScopeTM is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients. CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm. The device is intended to be used under supervision by qualified healthcare personnel. Caution: Federal (USA) law restricts this device to sale by or on order of a physician.

Source page: https://510kreport.com/device/K121266
Methodology: https://510kreport.com/methodology