# K170182: Cardiovit FT-1

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Jul 19, 2017 after 177 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: 15 generations back to K962603 (1997). 117 ancestors in all.
No later device cites it as a predicate yet.
1 of 118 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050686: Cardiovit at-10PLUS, Schiller AG (2005) Summary page 4.
- K152043: Diagnostic Station DS20, Schiller AG (2016) Summary page 5.

## Indications for use
The CARDIOVIT FT-1 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms. The CARDIOVIT FT-1 is designed for indoor use and can be used for all patient populations. The CARDIOVIT FT-1 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients. The CARDIOVIT FT-1 is intended for use in hospitals, cardiology units, out-patient clinical units and general physician's offices.

Source page: https://510kreport.com/device/K170182
Methodology: https://510kreport.com/methodology