# K191273: Multi-Link X2 ECG and SpO2 Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical, Inc.
- Decided: Sep 13, 2019 after 123 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)
- K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System, Carefusion 303, Inc. (2017) Summary page 5.

## Indications for use
The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor.

Source page: https://510kreport.com/device/K191273
Methodology: https://510kreport.com/methodology