# K143432: Cardio-TriTest

- Pathway: 510(k) (Traditional)
- Applicant: Cardio-Phoenix, Inc.
- Decided: Jun 3, 2015 after 184 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
Longest line of descent: 5 generations back to K930806 (1994). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081603: Digital Ballistocardiograph, Model DGB 300, Heartforce Medical, Inc. (2009) Summary page 5.
- K031517: Zargis Acoustic Cardioscan, Zargis Medical Corp. (2004) Summary page 5.

## Most influential descendants
- K182790: Cardio-TriTest v6.5 (2018), 0 descendants of its own

## Indications for use
The intended use of this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. The indication for use is as... a. a Standard 12 Lead Diagnostic ECG b. an aid to identify events in the cardiac cycle c. an aid to detect S1 & S2 hearts sounds and murmurs. Not intended for use in pediatrics. Not intended for patients in the intensive care units. Intended population: Males and females greater than or equal to 20 years of age. Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.

Source page: https://510kreport.com/device/K143432
Methodology: https://510kreport.com/methodology