# K211294: Multi-Link X2 ECG Cable and Leadwire System

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical, Inc.
- Decided: Aug 16, 2021 after 110 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: 5 generations back to K933649 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162432: Multi-Link X2 ECG Cable and Lead Wire System, Carefusion 2200, Inc. (2017) Summary page 5.

## Most influential descendants
- K240377: LIFEPAK® ECG Cables (2024), 0 descendants of its own

## Indications for use
The Multi-Link X2 ECG Cable and Leadwire 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.

Source page: https://510kreport.com/device/K211294
Methodology: https://510kreport.com/methodology