# K170995: Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 2, 2017 after 60 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; 1 cites 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)
- K152427: PC ECG, Edan Instruments, Inc. (2016) Summary page 4.
- K160876: PC ECG, Edan Instruments, Inc. (2017) Summary page 4.

## Most influential descendants
- K212278: Electrocardiograph (2022), 2 descendants of its own
- K222902: Electrocardiograph: SE-1200 Pro and SE-1201 Pro (2023), 1 descendant of its own
- K232210: X-trodes System M (2024), 0 descendants of its own

## Indications for use
The SE-18 18-lead electrocardiograph is intended 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/K170995
Methodology: https://510kreport.com/methodology