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LifePak 12 Defibrillator/Monitor System

by Medtronic Physio-Control Corp.

510(k) K010918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK010918 Date23 Aug 2001DecidedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1548-2011 FDA Unclassified (pre-2012) initiated 1 Oct 2010

    L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.

    • Terminated Z-0710-06 FDA Unclassified (pre-2012) initiated 22 Mar 2006

    Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

    • Terminated Z-0004-06 FDA Unclassified (pre-2012) initiated 12 Jul 2005

    Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).

    • Terminated Z-0542-03 FDA Unclassified (pre-2012) initiated 27 Jan 2003

    Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LifePak 12 Defibrillator/Monitor System is an automated external defibrillator designed for emergency cardiac resuscitation. It delivers synchronized and unsynchronized electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest, while continuously monitoring vital signs and ECG waveforms for real-time assessment of cardiac activity.

This system is intended for single-use in clinical and pre-hospital settings, including hospitals, ambulances, and public access defibrillation programs. Supplied as a reusable device with disposable electrodes, it operates in both manual and semi-automatic modes, featuring a shock advisory system and a large display for simultaneous viewing of up to three ECG channels. Authorized under FDA 510(k) clearance (K010918) as a Class III device, it adheres to regulatory standards for cardiovascular emergency response equipment.

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