# K182790: Cardio-TriTest v6.5

- Pathway: 510(k) (Special)
- Applicant: Cardio-Phoenix, Inc.
- Decided: Dec 14, 2018 after 74 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: 6 generations back to K930806 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143432: Cardio-TriTest, Cardio-Phoenix, Inc. (2015) Summary page 6.

## Indications for use
The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and 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. 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/K182790
Methodology: https://510kreport.com/methodology