# K131819: PC ECG

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 22, 2013 after 155 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: 7 generations back to K903644 (1991). 13 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102854: PC ECG, Edan Instruments, Inc. (2010) Summary page 1.
- K052556: CG-7000DX-BT Ecg Recorder/Transmitter, Card Guard Scientific Survival, Ltd. (2006) Summary page 1.

## Most influential descendants
- 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
- K212278: Electrocardiograph (2022), 2 descendants of its own

## Indications for use
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG Signal from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K131819
Methodology: https://510kreport.com/methodology