← Back to catalogue

Lifepak 500

FDA 510(k)

Class III (US FDA 510(k))

510(k) K955854

by Physio-Control Corp.

Identifiers

510(k) Number
K955854 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LifePak 500 is an Automated External Defibrillator (Non-Wearable), designed to deliver biphasic defibrillation waveforms for the treatment of cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia. It provides automated analysis of heart rhythms and delivers synchronized cardioversion or defibrillation shocks as clinically indicated, with adaptive biphasic technology to optimize energy delivery.

This device is intended for use in emergency cardiac resuscitation by trained responders, including healthcare professionals, first responders, and lay rescuers. Supplied as a reusable medical device, it requires proper maintenance and calibration per manufacturer guidelines. The LifePak 500 is classified as a Class III device under FDA regulations (870.5310) and holds a Traditional 510(k) clearance with a Cardiovascular advisory committee review. It is not MRI-compatible and must be stored in accordance with manufacturer instructions to ensure operational readiness.

Frequently asked questions

What types of cardiac emergencies is the LifePak 500 designed to address, and who can use it?

The LifePak 500 is specifically designed to treat cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. It is intended for use by trained responders, including healthcare professionals, first responders, and lay rescuers, during emergency cardiac resuscitation.

Is the LifePak 500 a single-use device or reusable, and what maintenance is required?

The LifePak 500 is a reusable medical device. It requires proper maintenance and calibration as outlined by the manufacturer to ensure reliable performance and operational readiness.

How is the LifePak 500 different from other defibrillators in terms of the energy it delivers?

The LifePak 500 delivers biphasic defibrillation waveforms, which are optimized for energy delivery through adaptive biphasic technology. This technology helps improve the effectiveness of shocks for treating ventricular fibrillation or pulseless ventricular tachycardia compared to traditional monophasic waveforms.

Can the LifePak 500 be used in an MRI environment, and how should it be stored?

The LifePak 500 is explicitly stated as not MRI-compatible, so it should never be used in an MRI environment. Storage must follow the manufacturer’s instructions to ensure the device remains operational and ready for use.

What regulatory pathway was followed for the LifePak 500’s approval, and what classification does it hold?

The LifePak 500 holds a Traditional 510(k) clearance from the FDA, reviewed by the Cardiovascular Advisory Committee. It is classified as a Class III device under FDA regulations (870.5310), indicating it is a high-risk medical device requiring stringent oversight.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Lifepak 500 AED Operation Manual, PDF PHYSIO·CONTROL LIFEPAK® 500 - heartfeltresponse.com, Medtronic Physio-Control LIFEPAK 500 Defibrillator Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K955854 24 fields · synced Sep 18, 2026