# K152427: PC ECG

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 5, 2016 after 163 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: 8 generations back to K903644 (1991). 14 ancestors in all.
11 later devices descend from it; 3 cite 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)
- K131819: PC ECG, Edan Instruments, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K222902: Electrocardiograph: SE-1200 Pro and SE-1201 Pro (2023), 1 descendant of its own

## Indications for use
SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.

Source page: https://510kreport.com/device/K152427
Methodology: https://510kreport.com/methodology