# K141946: Digital Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Decided: Feb 13, 2015 after 211 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 K842308 (1984). 25 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 29 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 5.
- K050858: Ascentia Heartstation Ecg Management System, Heartlab, Inc. (2005) Summary page 5.

## Most influential descendants
- K160092: Digital Electrocardiograph (2016), 1 descendant of its own
- K233266: Mediblu Ecg System (2024), 0 descendants of its own
- K171517: Digital Electrocardiograph (2018), 0 descendants of its own

## Indications for use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG c¢lectrodes. 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/K141946
Methodology: https://510kreport.com/methodology