# K980582: Multi-Link Cable and Lead Wire Systems

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Mar 16, 1998 after 27 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: 1 generation back to K933649 (1994). 1 ancestor in all.
10 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933649: Conmed Ecg Patient Cables and Leadwires, Conmedcorp (1994) Summary page 1.

## Most influential descendants
- K082851: Multlink Cable and Leadwire System (2008), 7 descendants of its own
- K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 (2010), 6 descendants of its own
- K162432: Multi-Link X2 ECG Cable and Lead Wire System (2017), 3 descendants of its own
- K211294: Multi-Link X2 ECG Cable and Leadwire System (2021), 1 descendant of its own
- K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (2017), 1 descendant of its own

## Indications for use
Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.

Source page: https://510kreport.com/device/K980582
Methodology: https://510kreport.com/methodology