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Lifepak 300

FDA 510(k)

Class III (US FDA 510(k))

510(k) K962359

by Physio-Control Corp.

Identifiers

510(k) Number
K962359 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 300 is an Automated External Defibrillator (Non-Wearable), designed to deliver high-energy shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist first responders or lay users in performing cardiopulmonary resuscitation (CPR) and defibrillation procedures.

This device is intended for single-use or reusable applications in pre-hospital and emergency settings, depending on the configuration. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The LifePak 300 is supplied with various accessories and electrodes tailored for adult, pediatric, and infant use, ensuring compatibility across different patient demographics.

Frequently asked questions

Can the LifePak 300 be used for both adults and pediatric patients, and if so, how is this achieved?

Yes, the LifePak 300 is designed for use across all patient demographics, including adults, pediatric, and infant patients. This is achieved through its compatibility with various supplied accessories and electrodes specifically tailored for each age group, ensuring appropriate defibrillation settings and electrode placement for safe and effective use.

Is the LifePak 300 intended for single-use only, or can it be reused after cleaning and maintenance?

The LifePak 300 is designed for both single-use and reusable applications, depending on the configuration and setting. While it can be used in pre-hospital and emergency environments, its reusable nature allows for maintenance and reuse in controlled environments where proper cleaning and servicing protocols are followed. Always refer to manufacturer guidelines for reuse procedures.

What type of regulatory clearance does the LifePak 300 hold, and which U.S. regulatory body approved it?

The LifePak 300 holds FDA 510(k) clearance, meaning it was determined to be substantially equivalent to a predicate device already on the market. The U.S. Food and Drug Administration (FDA) approved it under the Class III classification for medical devices, which includes high-risk devices like automated external defibrillators, ensuring rigorous review and compliance with safety standards.

Does the LifePak 300 provide guidance to users during CPR and defibrillation, and how is this guidance delivered?

Yes, the LifePak 300 includes voice prompts and visual guidance to assist users—whether first responders or laypersons—in performing CPR and defibrillation procedures. This hands-free support ensures proper technique and timing, improving the likelihood of successful resuscitation by reducing user error during critical moments.

What types of accessories or electrode configurations are included with the LifePak 300 to ensure compatibility with different patient sizes?

The LifePak 300 is supplied with specialized electrodes designed for adult, pediatric, and infant use. These configurations ensure correct energy delivery and electrode placement tailored to the patient’s age and size, optimizing the device’s effectiveness for each demographic group.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K962359 24 fields · synced Sep 18, 2026