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HeartStart FR3 Automated External Defibrillator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K130684

by Philips Medical Systems

Identifiers

510(k) Number
K130684 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 HeartStart FR3 Automated External Defibrillator is a Class III medical device designed for emergency resuscitation. It is an automated external defibrillator (non-wearable) that delivers electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest, specifically ventricular fibrillation (VF) or certain ventricular tachycardias (VT).

This device is intended for use by trained responders in pre-hospital or clinical settings. Supplied as a reusable unit, it operates on a battery and includes adult pads. The HeartStart FR3 has received FDA 510(k) clearance under the Traditional pathway, with a decision date of October 18, 2013, and is regulated under the classification 870.5310. It is not specified as MRI-safe or single-use.

Frequently asked questions

What is the primary purpose of the Philips HeartStart FR3 Automated External Defibrillator, and who is it intended for?

The Philips HeartStart FR3 is designed to restore normal heart rhythm in patients experiencing sudden cardiac arrest caused by ventricular fibrillation (VF) or certain ventricular tachycardias (VT). It is intended for use by trained responders in pre-hospital or clinical settings, such as emergency medical technicians, paramedics, or healthcare professionals trained in cardiopulmonary resuscitation (CPR) and defibrillation.

Is the Philips HeartStart FR3 a single-use or reusable device, and what does this mean for maintenance?

The Philips HeartStart FR3 is a reusable unit, meaning it is not designed for single-use disposal. This allows for repeated use in emergency situations, but it requires regular maintenance, including battery checks, pad inspections, and software updates, to ensure reliable performance over time.

What power source does the Philips HeartStart FR3 use, and does it come with any accessories?

The Philips HeartStart FR3 operates on a battery, which is included as part of the device. It is supplied with adult defibrillation pads, which are essential for delivering the electrical shocks needed to treat ventricular fibrillation or certain ventricular tachycardias.

How is the regulatory status of the Philips HeartStart FR3 Automated External Defibrillator defined, and what does this imply for its use?

The Philips HeartStart FR3 received FDA 510(k) clearance under the Traditional pathway, with a decision date of October 18, 2013. This means it has been deemed substantially equivalent to a legally marketed device and is classified as a Class III medical device under regulation number 870.5310, ensuring it meets strict safety and effectiveness standards for emergency resuscitation.

Are there any specific storage requirements or considerations for the Philips HeartStart FR3?

While the device data does not specify detailed storage conditions, as a reusable medical device, the Philips HeartStart FR3 should be stored in a clean, dry environment away from extreme temperatures or direct sunlight. Proper storage ensures battery longevity and device functionality, particularly in emergency settings where reliable performance is critical.

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: Philips - HeartStart FR3 Defibrillator, Philips HeartStart FR3 AED Documents - AED Brands, PDF FR3 Setup Guide 453564303641USonly - Philips, Global home | Philips, Philips HeartStart FR3 AED Defibrillator - 861388 - American AED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (1)

  • FDA 510(k) K130684 24 fields · synced Sep 18, 2026