# 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

- Pathway: 510(k) (Abbreviated)
- Applicant: Integral Process Sas
- Decided: Aug 16, 2017 after 320 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 4.
- K992524: Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires, Advantage Medical Electronics, Inc. (2000) Summary page 4.
- K082959: Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors, Unimed Medical Supplies, Inc. (2008) Summary page 4.

## Most influential descendants
- K252827: IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) (2025), 0 descendants of its own
- K251669: IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m;  IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (2025), 0 descendants of its own

## Indications for use
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.

Source page: https://510kreport.com/device/K162768
Methodology: https://510kreport.com/methodology