# K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Jun 22, 2017 after 211 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.
1 later device descends from it; 1 cites 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)
- 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
- K191273: Multi-Link X2 ECG and SpO2 Adapter (2019), 0 descendants of its own

## Indications for use
The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

Source page: https://510kreport.com/device/K163316
Methodology: https://510kreport.com/methodology