Skip to content

LifePak 500 Automated External Defibrillator

by Medtronic Emergency Response Systems, Inc.

510(k) K052057

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Traditional NumberK052057 Date17 Feb 2006ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1633-2020 FDA Class II initiated 20 Mar 2020

    Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

    • Terminated Z-1773-2013 FDA Class II initiated 12 Jun 2013

    The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.

    • Terminated Z-2885-2011 FDA Unclassified (pre-2012) initiated 6 Jun 2011

    The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.

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  • Withdrawn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 500 Automated External Defibrillator is a Class III medical device classified as an Automated External Defibrillator (Non-Wearable). It is designed to deliver an electric shock to the chest of a patient in cardiac arrest to restore normal heart rhythm, with automated voice prompts and shock advisory to guide non-medical users through resuscitation procedures.

This device is intended for single-use in emergency cardiac care settings, including pre-hospital, hospital, and public access environments. Supplied as a non-sterile, reusable unit with replaceable electrodes and batteries, it must be stored in a dry environment and maintained according to manufacturer instructions. The LifePak 500 holds an FDA 510(k) clearance under the Cardiovascular advisory committee and complies with regulation number 870.5310.

Other devices from Medtronic Emergency Response Systems, Inc.

Questions

AI-generated answers, 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.

  • Is the LifePak 500 Automated External Defibrillator designed for repeated use in clinical settings, or is it intended for single-use only?

    The LifePak 500 is explicitly designed for single-use in emergency cardiac care settings, including pre-hospital, hospital, and public access environments. While the main unit itself is reusable, it requires replacement of electrodes and batteries for each use, ensuring compliance with single-use protocols in critical scenarios.

  • What storage conditions are required for the LifePak 500, and how does this affect its usability in different environments?

    The device must be stored in a dry environment to maintain functionality. This requirement ensures reliability in environments like ambulances, public access locations, or hospitals where humidity or moisture could compromise performance. Proper storage aligns with the manufacturer’s instructions to preserve the unit’s operational integrity for emergency use.

  • Are the electrodes for the LifePak 500 reusable, or do they need to be replaced after each use?

    The LifePak 500 is supplied with replaceable electrodes, meaning they are designed for single-use only. This aligns with the device’s intended use in emergency cardiac care, where sterility and performance consistency are critical for effective defibrillation. Replacement electrodes ensure each use adheres to best practices for patient safety.

  • What regulatory pathway was followed for the FDA clearance of the LifePak 500, and which advisory committee was involved?

    The LifePak 500 received FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee, following a traditional review process. The device was classified as substantially equivalent to a predicate under regulation number 870.5310, confirming its compliance with U.S. medical device regulations for automated external defibrillators.