# K162432: Multi-Link X2 ECG Cable and Lead Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200, Inc.
- Decided: Jan 18, 2017 after 140 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: 4 generations back to K933649 (1994). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980582: Multi-Link Cable and Lead Wire Systems, Marquette Medical Systems, Inc. (1998) Summary page 4.
- K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8, Kepler Medtec (2010) Summary page 4.

## Most influential descendants
- K211294: Multi-Link X2 ECG Cable and Leadwire System (2021), 1 descendant of its own
- K240377: LIFEPAK® ECG Cables (2024), 0 descendants of its own
- K200510: Multi-LinkTM X2 ECG Adapter and Leadwires (2020), 0 descendants of its own

## Indications for use
The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables (care cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable and disposable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

Source page: https://510kreport.com/device/K162432
Methodology: https://510kreport.com/methodology