# K131503: SE-601 Series Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 25, 2014 after 277 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). 14 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092010: PC Ecg, Model SE-1010, Edan Instruments, Inc. (2009) Summary page 1.
- K093869: SE-601 Series Electrocardiograph, Edan Instruments, Inc. (2010) Summary page 1.

## 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
The intended use of SE-601 is to acquire EGG signals from adult and pediatric patients through body surface EGG 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 EG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K131503
Methodology: https://510kreport.com/methodology