# K982448: Cardiolight

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Jun 11, 1999 after 331 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K830013 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830013: Epi Cardia Sys. - Ambulatory Monitor, Medicomp, Inc. (1983) Summary page 2.

## Indications for use
The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.

Source page: https://510kreport.com/device/K982448
Methodology: https://510kreport.com/methodology