# K212278: Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Apr 7, 2022 after 261 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: 11 generations back to K903644 (1991). 39 ancestors in all.
2 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)
- K170995: Electrocardiograph, Edan Instruments, Inc. (2017) Summary page 4.

## Most influential descendants
- 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 iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

Source page: https://510kreport.com/device/K212278
Methodology: https://510kreport.com/methodology