# K973403: Cardiosmart ST

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Mar 12, 1998 after 184 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903644 (1991). 3 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950989: Cardiosmart, Hellige GmbH (1996) Summary page 1.
- K951130: Cardiosoft/Cardiosys, Marquette Electronics, Inc. (1996) Summary page 1.
- K903644: Series 1500 12-Lead Analysis Option, Marquette Electronics, Inc. (1991) Summary page 1.

## Most influential descendants
- 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
- K102854: PC ECG (2010), 13 descendants of its own

## Indications for use
CardioSmart ST is an ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH. CardioSmart ST is intended to be used for resting ECG and stress test ECG and for recording ECG in real-time without arrhythmia detection. It is intended to be used by trained operators when ECG records are required in the judgement of a physician. ECG may be interpreted by optionally available analysis program. CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion. CardioSmart ST is not intended for use as a vital signs physiological monitor. CardioSmart ST is not designed for intracardial use. CardioSmart ST is not intended for home use.

Source page: https://510kreport.com/device/K973403
Methodology: https://510kreport.com/methodology