# K160092: Digital Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Decided: Feb 12, 2016 after 28 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 K842308 (1984). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141946: Digital Electrocardiograph, Shenzhen Biocare Bio-Medical Equipment Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K233266: Mediblu Ecg System (2024), 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 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. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Source page: https://510kreport.com/device/K160092
Methodology: https://510kreport.com/methodology