# K112431: Digital Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Biocare Electronics Co., Ltd.
- Decided: Sep 22, 2011 after 30 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: 6 generations back to K921669 (1993). 11 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101876: Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010, Shenzhen Biocare Electronics Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K122712: Digital Electrocardiograph (2012), 8 descendants of its own
- K123816: Digital Electrocardiographs (2013), 4 descendants of its own
- K133985: Digital Electrocardiograph (2015), 1 descendant of its own
- K131900: Contec Electrocardiograph (2014), 1 descendant of its own
- K132758: Digital Electrocardiograph (2014), 1 descendant of its own

## Indications for use
Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K112431
Methodology: https://510kreport.com/methodology