# K950989: Cardiosmart

- Pathway: 510(k) (Traditional)
- Applicant: Hellige GmbH
- Decided: May 13, 1996 after 437 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hellige Cardiognost EK 56: named in the summary without a submission number

## Most influential descendants
- K973403: Cardiosmart ST (1998), 34 descendants of its own
- K991014: Case 8000 Exercise Testing System (1999), 33 descendants of its own
- K023380: T-Wave Altermans (Twa) Algorithm Option (2002), 31 descendants of its own
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own
- K092010: PC Ecg, Model SE-1010 (2009), 18 descendants of its own

## Indications for use
CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection. CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician. The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation. CardioSmart does not provide alarms for arrhythmia detection. CardioSmart is not intended for use as a vital signs physiological monitor. CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion. CardioSmart is not designed for intracardial use. CardioSmart is not intended for home use.

Source page: https://510kreport.com/device/K950989
Methodology: https://510kreport.com/methodology