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LifePak 12 Defibrillator/Monitor

by Medtronic Emergency Response Systems, Inc. 2 variants

510(k) K063510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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)SESE Substantially Equivalent · Special NumberK063510 Date26 Jan 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0811-2010 FDA Unclassified (pre-2012) initiated 31 Mar 2009

    Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.

    • Terminated Z-1904-2008 FDA Unclassified (pre-2012) initiated 16 Apr 2008 on shared 510(k) K063510

    The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to analys

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
SESE Substantially Equivalent

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 is an automated external defibrillator (non-wearable) designed to deliver synchronized and unsynchronized cardioversion and defibrillation. It provides real-time ECG monitoring, rhythm analysis, and automated shock advisory for emergency cardiac care, supporting both manual and semiautomatic operation.

Supplied as a reusable medical device, the LifePak 12 is intended for use in acute cardiac care settings, including hospital and pre-hospital environments. It is regulated under FDA 510(k) clearance (K063510) as a Class III device, adhering to 21 CFR 870.5310. The device is not MRI-compatible and requires proper maintenance, calibration, and storage as outlined in manufacturer guidelines.

Other devices from Medtronic Emergency Response Systems, Inc.