# K171942: Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 24, 2018 after 210 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: 10 generations back to K903644 (1991). 38 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160876: PC ECG, Edan Instruments, Inc. (2017) Summary page 4.

## Most influential descendants
- K210140: electrocardiograph: SE-1202 (2021), 1 descendant of its own
- K252463: SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (2026), 0 descendants of its own
- K220362: LE-12CH (2022), 0 descendants of its own

## Indications for use
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) 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/K171942
Methodology: https://510kreport.com/methodology