# K090834: Epicardia 5000

- Pathway: 510(k) (Special)
- Applicant: Medicomp, Inc.
- Decided: May 15, 2009 after 49 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090207: Epicardia 4000. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K173170: Epicardia Anywhere (2018), 0 descendants of its own

## Indications for use
The EPICARDIA System is designed to acquire, store and analyze ECG signals from ECG electrodes on ambulatory patients. Epicardia is a software application that receives the data from patient monitors, provides user operations for editing the results of the analysis and then formats the data for printing. The system is to be used by a trained operator; the summary reports should be confirmed by a qualified clinician.

Source page: https://510kreport.com/device/K090834
Methodology: https://510kreport.com/methodology