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LifePak 12, 20, 500, CR Plus

by Medtronic Physio-Control Corp.

510(k) K033275

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK033275 Date6 Nov 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2100-2016 FDA Class II initiated 25 May 2016

    LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.

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  • Withdrawn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, 20 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, 20, 500, CR Plus is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides semi-automated or fully automated defibrillation, shock analysis, and pacing capabilities, including biphasic waveform delivery for improved efficacy. The device is engineered for use by trained responders, including healthcare professionals and laypersons, in both pre-hospital and in-hospital settings. Its advanced features include voice prompts, real-time feedback, and compatibility with various electrode types to enhance user confidence and treatment success.

The LifePak 12, 20, 500, CR Plus is supplied as a reusable medical device, intended for single-patient use per session before reprocessing. It operates in environments requiring defibrillation, including emergency rooms, ambulances, and public access defibrillation sites. The device is not MRI-safe and must be used in non-magnetic areas. Storage requires adherence to manufacturer guidelines for cleaning, disinfection, and maintenance to ensure functionality and sterility. Authorized under FDA 510(k) clearance (K033275) as Substantially Equivalent (SESE), it falls under Class III regulatory classification (21 CFR 870.5310) for high-risk, life-sustaining devices.

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