# K161302: PC ECG

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jul 1, 2016 after 53 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: 9 generations back to K903644 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152427: PC ECG, Edan Instruments, Inc. (2016) Summary page 4.

## Most influential descendants
- K191692: KardioScreen (2020), 0 descendants of its own

## Indications for use
The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.

Source page: https://510kreport.com/device/K161302
Methodology: https://510kreport.com/methodology