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LifePak 1000

by Medtronic Emergency Response Systems, Inc.

510(k) K042404

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 · Traditional NumberK042404 Date22 Dec 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1660-2014 FDA Class II initiated 9 May 2014

    Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100

    • Terminated Z-1656-2008 FDA Unclassified (pre-2012) initiated 27 Feb 2008

    Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Lifepak, Model 1000
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 1000 is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It analyzes heart rhythms and advises whether a shock is required, providing automated guidance for emergency responders.

Supplied as a reusable device, the LifePak 1000 is intended for use in pre-hospital and clinical settings, including emergency medical services (EMS) and hospitals. It requires proper maintenance, testing, and calibration as outlined in manufacturer service manuals. The device holds FDA 510(k) clearance under classification III and is regulated under 870.5310, with a registration number of 1218058 among others.

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 1000 designed for single-use or reusable applications in emergency settings?

    The LifePak 1000 is explicitly designed as a reusable device for use in pre-hospital and clinical settings, including emergency medical services (EMS) and hospitals. Since it requires maintenance, testing, and calibration as outlined in the manufacturer’s service manuals, it is not intended for single-use.

  • What types of environments is the LifePak 1000 approved for use in?

    The LifePak 1000 is approved for use in pre-hospital and clinical settings, such as emergency medical services (EMS) and hospitals. Its design and regulatory clearance (FDA 510(k)) reflect its intended application in environments where sudden cardiac arrest may occur and immediate defibrillation is required.

  • How is the LifePak 1000’s regulatory status defined, and what does that mean for its use?

    The LifePak 1000 holds FDA 510(k) clearance under classification III, meaning it is deemed *substantially equivalent* to a legally marketed predicate device. This clearance allows it to be legally marketed and used in the U.S. for its intended purpose—delivering electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest—while adhering to strict regulatory oversight.

  • Does the LifePak 1000 require any special handling or storage conditions?

    While the provided data does not specify exact storage conditions, the LifePak 1000 is a reusable medical device that requires proper maintenance, testing, and calibration as outlined in the manufacturer’s service manuals. This implies it should be stored in a clean, controlled environment to ensure reliability and functionality when needed for emergency use.