# K160876: PC ECG

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 15, 2017 after 322 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). 37 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102830: Electrocardiograph, Edan Instruments, Inc. (2010) Summary page 4.
- K131503: SE-601 Series Electrocardiograph, Edan Instruments, Inc. (2014) Summary page 4.
- K060167: Atria 3100, Atria 6100, Cardiac Science Corporation (2006) Summary page 4.
- K152427: PC ECG, Edan Instruments, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K210140: electrocardiograph: SE-1202 (2021), 1 descendant of its own

## Indications for use
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph 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.

Source page: https://510kreport.com/device/K160876
Methodology: https://510kreport.com/methodology