LIFEPAK ECG Cables
510(k) K240377
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240377 | Date7 May 2024 | StatusActive |
Recalls
-
- Ongoing Z-1102-2025
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The device is a cable, transducer and electrode, patient, including connector, as defined in the device name and specifications. It is substantially equivalent to a predicate device and classified as a Class II medical device under FDA regulation number 870.2900.
The device is supplied by Stryker Physio-Control and has received FDA 510(k) clearance under K240377. It is intended for use in cardiovascular applications and is manufactured at the address in Redmond, WA.
Other devices from Stryker Physio-Control
Questions
AI-generated answers, 22 Sep 2026
What is the LIFEPAK® ECG Cable used for?
The LIFEPAK® ECG Cable is intended for use in cardiovascular applications as a patient cable, transducer and electrode system including connector, to acquire ECG signals from patients during monitoring or diagnostic procedures.
How is the LIFEPAK® ECG Cable supplied and is it sterile or reusable?
The device is supplied by Stryker Physio-Control as a non-sterile, reusable patient cable system that requires proper cleaning and disinfection between uses according to the manufacturer’s instructions for use.
What regulatory pathway was used for the LIFEPAK® ECG Cable?
The LIFEPAK® ECG Cable received FDA 510(k) clearance under submission number K240377, demonstrating substantial equivalence to a predicate device and is classified as a Class II medical device under regulation 870.2900.