# K102830: Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 2, 2010 after 64 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: 5 generations back to K921669 (1993). 10 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014108: Mac 5000 Ecg Analysis System, General Electric Medical Systems Information Techn (2002) Summary page 1.
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200, Edan Instruments, Inc. (2009). Our reading of the summary gave K041513, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SMART ECG SERIES ELECTROCARDIOGRAPH”.

## 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
SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. Trhe cardiogram recorded by SE-12 series can help users to analyze and diagnose heart disease. However the EGG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Source page: https://510kreport.com/device/K102830
Methodology: https://510kreport.com/methodology