# K240377: LIFEPAK® ECG Cables

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Physio-Control
- Decided: May 7, 2024 after 90 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933649 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211294: Multi-Link X2 ECG Cable and Leadwire System, Vyaire Medical, Inc. (2021) Summary page 4.

## Recalls of this device
- Jan 21, 2025 · Class II · Z-1102-2025: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

## Indications for use
The LIFEPAK ECG cables are reusable electrode cable systems intended to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. LIFEPAK ECG cables are intended for use in outdoor and indoor emergency care settings. LIFEPAK ECG Cables: - LIFEPAK 3-wire ECG Cable - LIFEPAK 5-wire ECG Cable - LIFEPAK 4-wire ECG cable - LIFEPAK 3-wire extended precordial ECG Cable - LIFEPAK 6-wire expandable precordial ECG cable

Source page: https://510kreport.com/device/K240377
Methodology: https://510kreport.com/methodology