# K173170: Epicardia Anywhere

- Pathway: 510(k) (Special)
- Applicant: Medicomp, Inc.
- Decided: Jan 10, 2018 after 103 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K090834 (2009). 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)
- K090834: Epicardia 5000, Medicomp, Inc. (2009) Summary page 4.

## Indications for use
The Epicardia Anywhere is indicated as a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient’s ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

Source page: https://510kreport.com/device/K173170
Methodology: https://510kreport.com/methodology