# K182327: Patient Cables and Leadwires , Disposable ECG Leadwires

- Pathway: 510(k) (Traditional)
- Applicant: Orantech, Inc.
- Decided: Jan 30, 2019 after 156 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 5.

## Indications for use
The device is 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/K182327
Methodology: https://510kreport.com/methodology