Lifepak 12DEFIBERLLATOR/Monitor Series
by Medtronic Physio-Control Corp.
510(k) K002445
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK002445 | Date31 Jan 2001 | StatusActive |
Recalls
-
- Terminated Z-0542-03
Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- ST
Overview
AI-generated summary, 18 Sep 2026
The LifePak 12 Defibrillator/Monitor Series is an Automated External Defibrillator (Non-Wearable) designed to deliver synchronized and unsynchronized electrical shocks for the treatment of cardiac arrhythmias, including ventricular fibrillation and pulseless ventricular tachycardia. It also provides real-time electrocardiogram (ECG) monitoring, rhythm analysis, and voice prompts to guide resuscitation efforts during cardiac emergencies.
This device is intended for use in pre-hospital, hospital, and clinical settings by trained healthcare professionals. Supplied as a reusable medical device, it requires proper maintenance and calibration per manufacturer guidelines. The LifePak 12 Series operates under FDA 510K clearance (K002445) and adheres to Class III regulatory standards (870.5310). Multiple model variants are tracked under the registration numbers provided, ensuring compliance with cardiovascular device regulations.