# K101876: Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Biocare Electronics Co., Ltd.
- Decided: Mar 1, 2011 after 238 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.
13 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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) Summary page 1.

## Most influential descendants
- K112431: Digital Electrocardiograph (2011), 9 descendants of its own
- K122712: Digital Electrocardiograph (2012), 8 descendants of its own
- K123816: Digital Electrocardiographs (2013), 4 descendants of its own
- K113485: Electrocardiograph (2012), 3 descendants of its own
- K133985: Digital Electrocardiograph (2015), 1 descendant of its own

## Indications for use
Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, 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/K101876
Methodology: https://510kreport.com/methodology