# K191428: ECG Cable

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
- Decided: Nov 27, 2019 after 182 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K992524 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120010: Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure), Shenzhen Med-Link Electronics Tech Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K200026: Disposable ECG Cable (2020), 0 descendants of its own

## Indications for use
The ECG Cable is intended to be used with ECG. The ECG Cable is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

Source page: https://510kreport.com/device/K191428
Methodology: https://510kreport.com/methodology