# K200510: Multi-LinkTM X2 ECG Adapter and Leadwires

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical, Inc.
- Decided: Oct 9, 2020 after 221 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.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
The Multi-Link.TM X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.

Source page: https://510kreport.com/device/K200510
Methodology: https://510kreport.com/methodology