# K203635: Patient Monitoring Cables

- Pathway: 510(k) (Traditional)
- Applicant: Jkh USA, LLC
- Decided: Feb 5, 2021 after 53 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: 10 generations back to K941811 (1994). 39 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 42 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 4.
- K142489: Unimed Disposable ECG lead wires, Unimed Medical Supplies, Inc. (2014) Summary page 4.

## Most influential descendants
- K240156: LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (2024), 0 descendants of its own
- K222712: Fogg System Patient Monitoring Cables (2023), 0 descendants of its own

## Indications for use
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables 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/K203635
Methodology: https://510kreport.com/methodology