# K102854: PC ECG

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 3, 2010 after 65 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 K903644 (1991). 9 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K092010: PC Ecg, Model SE-1010, Edan Instruments, Inc. (2009)

## Most influential descendants
- K131819: PC ECG (2013), 12 descendants of its own
- K152427: PC ECG (2016), 11 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own
- K171942: Electrocardiograph (2018), 3 descendants of its own
- K170995: Electrocardiograph (2017), 3 descendants of its own

## Indications for use
SE-l10l1 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE- 10 10 PC ECGI is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-lol10 PC ECG can help users to analyze and diagnose heart disease. However the ECGI with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K102854
Methodology: https://510kreport.com/methodology