# K220447: Med-link Disposable ECG Cable and Leadwires

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jun 28, 2022 after 132 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional. Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Source page: https://510kreport.com/device/K220447
Methodology: https://510kreport.com/methodology