HeartStart FR3 Defibrillator (Models 861388, 861389)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Philips HeartStart FR3 Defibrillator FDA PMA
- Generic Name
- Automated external defibrillators (non-wearable) FDA PMA
Identifiers
- PMA Number
- P160028 FDA PMA
- FDA Product Code
- MKJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5310 FDA PMA
- Regulation Number
- 870.5310 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The HeartStart FR3 Defibrillator is an automated external defibrillator (non-wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT). It is intended for use by trained responders in emergency cardiac arrest scenarios, including unresponsive individuals without normal breathing or pulse.
This device is supplied as a reusable medical instrument and is approved for use with SmartPads III or DP defibrillator pads. It is indicated for adults and children over 55 pounds (25 kg) or eight years old, with an optional Infant/Child Key for use in younger patients. The HeartStart FR3 Defibrillator holds an FDA PMA approval (P160028) and is classified as a Class III device under regulation number 870.5310.
Frequently asked questions
What is the primary use case for the Philips HeartStart FR3 Defibrillator, and who is it intended for?
The Philips HeartStart FR3 Defibrillator is designed for trained responders to treat patients experiencing ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT), which are common causes of sudden cardiac arrest. It is intended for use on unresponsive individuals without normal breathing or pulse. The device is approved for adults and children over 55 pounds (25 kg) or eight years old. For younger children under 55 pounds, an optional Infant/Child Key must be used, ensuring safe and effective treatment across a broader age range.
How is the Philips HeartStart FR3 Defibrillator supplied, and what pads are compatible with it?
The Philips HeartStart FR3 Defibrillator is supplied as a reusable medical instrument. It is compatible with Philips SmartPads III or DP defibrillator pads, which are specifically designed to work with this defibrillator model for delivering shocks to restore normal heart rhythm.
What are the key model numbers for the Philips HeartStart FR3 Defibrillator, and how do they relate to its intended use?
The Philips HeartStart FR3 Defibrillator includes the model numbers 861388 and 861389, both of which are approved for treating ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT) in patients who are unresponsive, not breathing normally, and without a pulse. These models are intended for adults and children over 55 pounds (25 kg) or eight years old, with the optional Infant/Child Key allowing use in younger patients under 55 pounds.
Is the Philips HeartStart FR3 Defibrillator approved for use in pediatric patients, and if so, what considerations apply?
Yes, the Philips HeartStart FR3 Defibrillator is approved for pediatric use, but with specific considerations. It is intended for children over 55 pounds (25 kg) or eight years old. For younger children under 55 pounds, the device must be used with the optional Infant/Child Key to ensure proper shock dosing and safety. If the Infant/Child Key is unavailable or the child’s age/weight is uncertain, treatment should not be delayed—standard adult pads can still be used, but caution is advised.
What regulatory pathway was followed for the Philips HeartStart FR3 Defibrillator, and what classification does it hold?
The Philips HeartStart FR3 Defibrillator follows the FDA Premarket Approval (PMA) pathway, as indicated by its PMA number (P160028). It is classified as a Class III device under regulation number 870.5310, reflecting its critical role in treating life-threatening cardiac emergencies. This classification requires rigorous pre-market approval due to the high-risk nature of defibrillators.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160028 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA PMA P160028 24 fields · synced Sep 18, 2026