# K120010: Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jan 19, 2012 after 16 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: 2 generations back to K992524 (2000). 2 ancestors in all.
17 later devices descend from it; 10 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082959: Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors, Unimed Medical Supplies, Inc. (2008) Summary page 5.
- K992524: Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires, Advantage Medical Electronics, Inc. (2000) Summary page 5.

## Most influential descendants
- K192404: Patient Monitoring Cable (SpO2 Extension Cable) (2020), 2 descendants of its own
- K162768: ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables (2017), 2 descendants of its own
- K170536: ECG Disposable Lead Wire (2017), 2 descendants of its own
- K222370: SpO2 Extension Cable (2023), 1 descendant of its own
- K191428: ECG Cable (2019), 1 descendant of its own

## Indications for use
Shenzhen Med-link Cable / lead-wire are intended to be used with ECG, EKG, SpO2 and Invasive Blood Pressure monitoring devices. The Cable / lead-wire are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Source page: https://510kreport.com/device/K120010
Methodology: https://510kreport.com/methodology