LifePak 500 Automated External Defibrillator

• • 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-0886-04 FDA Unclassified (pre-2012) ·initiated 2 Apr 2004

  Potential for batteries to malfunction due to battery cell rupture.

Full name

Modification to: Lifepak 500 Automated External Defibrillator

510(k) Number

K012428 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• LifePak 12 Defibrillator/Monitor System

  Class III

  FDA 510(k) K010918 Active Cleared 23 Aug 2001

• Lifepak 12

  Class III

  FDA 510(k) K040775 Active Cleared 23 Apr 2004

• LifePak 600 Automated External Defibrillator

  Class III

  FDA 510(k) K011144 Active Cleared 3 Dec 2001

• Lifepak 12DEFIBERLLATOR/Monitor Series

  Class III

  FDA 510(k) K002445 Active Cleared 31 Jan 2001

• Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker

  Class II

  FDA 510(k) K012274 Active Cleared 5 Feb 2002

• LifePak 12, 20, 500, CR Plus

  Class III

  FDA 510(k) K033275 Active Cleared 6 Nov 2003

See all devices from Medtronic Physio-Control Corp. →

• Is the LifePak 500 Automated External Defibrillator intended for single-use or reusable in emergency settings?

  The LifePak 500 is designed as a reusable device, intended specifically for use in pre-hospital and emergency response environments. Since it is not sterile, it requires proper maintenance, calibration, and cleaning between uses to ensure reliable performance in cardiac arrest scenarios.

• What type of regulatory clearance does the LifePak 500 modification hold, and how does it relate to its intended use?

  The LifePak 500 modification received FDA clearance through a 510(k) pathway, classified as substantially equivalent under the regulatory category 870.5310 for Automated External Defibrillators (Non-Wearable). This clearance confirms its compliance with U.S. safety and performance standards for analyzing heart rhythms and delivering shocks in cases of sudden cardiac arrest outside of hospitals.

• Can the LifePak 500 be used in an MRI environment, or are there specific storage or handling requirements?

  The LifePak 500 is explicitly not MRI-safe and must only be used in non-MRI environments. While the device itself isn’t stored in an MRI setting, its non-MRI-safe classification means it cannot be placed near MRI machines or used in areas where MRI procedures are conducted, even temporarily.

• What maintenance or calibration steps are necessary to ensure the LifePak 500 remains functional for emergency use?

  Since the LifePak 500 is reusable and not sterile, it requires adherence to the manufacturer’s guidelines for regular maintenance, calibration, and cleaning to guarantee reliable performance. Proper storage conditions are also critical, as the device’s functionality depends on consistent upkeep to ensure accurate rhythm analysis and effective shock delivery during cardiac emergencies.

• How does the LifePak 500 differ from other automated external defibrillators in terms of its regulatory and clinical focus?

  The LifePak 500 is specifically designed for emergency cardiac care outside of hospitals, targeting trained personnel in pre-hospital or first-responder settings. Its regulatory focus is on sudden cardiac arrest scenarios, with clearance under the FDA’s Cardiovascular advisory committee (CV) and classification as a Class III device. Unlike some defibrillators intended for hospital use, this model emphasizes portability and reliability in non-clinical environments.