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PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR - M3840a

FDA 510(k)

Class III (US FDA 510(k))

510(k) K051632

by Philips Medical Systems

Identifiers

510(k) Number
K051632 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
M3860a FDA 510(k)
M3861a FDA 510(k)
M3840a FDA 510(k)
M3841a 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 FR2+ Automated External Defibrillator (AED) is a Class III medical device designed for the delivery of electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides automated voice prompts, real-time analysis of heart rhythms, and biphasic defibrillation to improve resuscitation outcomes in pre-hospital and public-access settings.

This device is intended for single-use or reusable applications in emergency response scenarios, supplied as a portable unit for use by trained responders. It is not MRI-compatible and must be stored in a clean, dry environment as specified by the manufacturer. The HeartStart FR2+ holds FDA 510(k) clearance under the classification of Automated External Defibrillators (Non-Wearable) and adheres to regulatory requirements outlined in 21 CFR 870.5310.

Frequently asked questions

What are the key differences between the single-use and reusable applications of the Philips HeartStart FR2+ AED, and how should I decide which to use?

The Philips HeartStart FR2+ AED is designed for both single-use and reusable applications, making it versatile for different emergency response scenarios. Single-use pads are ideal for public-access settings where contamination risk is higher, ensuring hygiene and avoiding cross-infection. Reusable pads are better suited for professional responders (e.g., EMS) who maintain strict cleaning protocols between uses. The choice depends on your facility’s infection control policies, budget, and whether the device will be used in high-risk or controlled environments.

How should I store the HeartStart FR2+ AED to ensure it remains operational and compliant with manufacturer guidelines?

The device must be stored in a clean, dry environment to prevent damage or malfunctions. Avoid exposure to extreme temperatures, humidity, or direct sunlight. Since it is not MRI-compatible, it should also be kept away from magnetic fields. Regularly check the battery status and perform maintenance as per Philips’ instructions to ensure readiness for emergencies.

Are there different models of the HeartStart FR2+ AED, and if so, how do I determine which one is right for my needs?

Yes, the HeartStart FR2+ comes in four models: M3860A, M3861A, M3840A, and M3841A. While the exact distinctions between these models aren’t specified in the data, they likely differ in features like battery life, connectivity options, or additional software capabilities. For most pre-hospital or public-access use cases, any of these models will suffice for delivering biphasic defibrillation and automated voice prompts. Consult Philips’ documentation or a sales representative to confirm compatibility with your specific workflow.

What regulatory pathway does the HeartStart FR2+ AED follow, and how does this affect its use in the U.S.?

The HeartStart FR2+ holds FDA 510(k) clearance under the classification of *Automated External Defibrillators (Non-Wearable)*, with a decision code of *SESE* (Substantially Equivalent). This means it meets FDA standards for safety and effectiveness comparable to previously cleared devices. The clearance is tied to 21 CFR 870.5310, ensuring compliance with U.S. regulations for Class III medical devices. No additional approvals are required beyond standard procurement and maintenance protocols.

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: Global home | Philips

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) K051632 24 fields · synced Sep 18, 2026