# K170536: ECG Disposable Lead Wire

- Pathway: 510(k) (Traditional)
- Applicant: APK Technology Co., Ltd.
- Decided: Apr 24, 2017 after 60 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 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 5.

## Most influential descendants
- K211941: 9Line (2022), 0 descendants of its own
- K181089: SureLead Cable System (2020), 0 descendants of its own

## Indications for use
The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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/K170536
Methodology: https://510kreport.com/methodology