# K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jul 24, 2009 after 63 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921669 (1993). 9 ancestors in all.
32 later devices descend from it; 7 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)
- K014108: Mac 5000 Ecg Analysis System, General Electric Medical Systems Information Techn (2002) Summary page 1.

## Most influential descendants
- K101876: Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 (2011), 13 descendants of its own
- K112431: Digital Electrocardiograph (2011), 9 descendants of its own
- K102830: Electrocardiograph (2010), 9 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own
- K122712: Digital Electrocardiograph (2012), 8 descendants of its own

## Recalls of this device
- Sep 10, 2010 · Not classified · Z-0041-2012: The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is misla

## Indications for use
The intended use of electrocardiograph is 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only

Source page: https://510kreport.com/device/K091513
Methodology: https://510kreport.com/methodology