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HeartStart FR3 Automated External Defibrillator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K111693

by Philips Medical Systems

Identifiers

510(k) Number
K111693 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 non-wearable device designed for delivering defibrillation therapy to patients experiencing ventricular fibrillation or certain ventricular tachycardias. It is an automated external defibrillator (AED) intended to assist trained responders in treating sudden cardiac arrest by analyzing heart rhythms and delivering appropriate electrical shocks when required.

This device is supplied as a reusable, non-sterile medical instrument intended for use in pre-hospital, clinical, and public-access settings. It operates on battery power and is classified as a Class III medical device under FDA regulations (21 CFR 870.5310). The HeartStart FR3 is authorized for use in the United States following FDA 510(k) clearance (K111693) and is intended for single-patient use per session, with battery and electrode replacements as specified by the manufacturer.

Frequently asked questions

Is the Philips HeartStart FR3 AED designed for use by untrained individuals, or does it require specific training to operate effectively?

The Philips HeartStart FR3 is designed for use by trained responders, as it is an automated external defibrillator (AED) that analyzes heart rhythms and delivers shocks when needed. While it is automated in its decision-making, proper training is still essential to ensure correct electrode placement, patient assessment, and overall emergency response.

How is the Philips HeartStart FR3 AED supplied, and what does this mean for its reuse and maintenance?

The HeartStart FR3 is supplied as a reusable, non-sterile device, meaning it is intended for repeated use across multiple patients after proper cleaning, maintenance, and replacement of consumables like batteries and electrodes. This design allows for long-term deployment in pre-hospital, clinical, or public-access settings, but it requires adherence to manufacturer guidelines for cleaning, calibration, and part replacement to ensure safe and reliable operation.

What types of cardiac arrhythmias is the Philips HeartStart FR3 AED authorized to treat, and how does it determine when to deliver a shock?

The HeartStart FR3 is authorized to treat patients experiencing ventricular fibrillation or certain ventricular tachycardias. It analyzes the patient’s heart rhythm automatically and delivers an electrical shock only when it detects a shockable rhythm, guiding the user through voice prompts and visual cues to ensure proper electrode placement and treatment.

What regulatory pathway was followed for FDA clearance of the Philips HeartStart FR3 AED, and what does this mean for its compliance?

The Philips HeartStart FR3 received FDA 510(k) clearance (K111693) through a traditional review process, with a decision described as ‘Substantially Equivalent’ to a predicate device. This means the device meets FDA standards for safety and effectiveness as determined by the regulatory authority, ensuring compliance with U.S. medical device regulations under 21 CFR 870.5310 for Class III devices.

Is the Philips HeartStart FR3 AED intended for single-patient use per session, or can it be reused for multiple patients in quick succession?

The manufacturer specifies that the HeartStart FR3 is intended for single-patient use per session, meaning it should not be reused on another patient without proper cleaning, maintenance, and replacement of consumables (such as electrodes and batteries). This ensures hygiene and reliability for each emergency response.

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 Philips HeartStart FR3 AED User Manual | Heartsmart, 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) K111693 24 fields · synced Sep 18, 2026