LifePak 15 Monitor/Defibrillator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K103567 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 15 Monitor/Defibrillator is an automated external defibrillator (non-wearable) designed to deliver manual and semiautomatic defibrillation, noninvasive pacing, and advanced cardiac monitoring. It provides real-time ECG analysis, rhythm detection, and shock advisory capabilities to support emergency cardiac interventions.
This device is intended for single-use in prehospital and clinical settings, though reusable components may be specified per manufacturer guidelines. It is not MRI-safe and requires proper storage in a clean, dry environment. Authorized under FDA 510(k) clearance (K103567), it adheres to regulatory standards for Class III cardiovascular devices (regulation number 870.5310).
Frequently asked questions
Is the LifePak 15 Monitor/Defibrillator intended for repeated use in clinical settings, or is it designed for single-use only?
The LifePak 15 Monitor/Defibrillator is explicitly designed for single-use in prehospital and clinical settings, though the manufacturer may specify reusable components if used according to their guidelines. This aligns with its classification as a Class III cardiovascular device, where single-use is often standard for defibrillators to ensure reliability and sterility.
How should I store the LifePak 15 Monitor/Defibrillator to maintain its functionality and safety?
The device requires storage in a clean, dry environment. Since it is not MRI-safe, it should also be kept away from magnetic fields. Proper storage conditions help preserve its performance, especially for emergency use where reliability is critical.
What key features does the LifePak 15 Monitor/Defibrillator provide to assist in emergency cardiac interventions?
The LifePak 15 delivers manual and semiautomatic defibrillation, noninvasive pacing, and advanced cardiac monitoring, including real-time ECG analysis and rhythm detection. Its shock advisory capabilities help guide clinicians during critical interventions, making it suitable for both prehospital and clinical emergency responses.
What regulatory pathway was followed for FDA clearance of the LifePak 15 Monitor/Defibrillator, and what does this mean for its use?
The device was cleared via a traditional 510(k) pathway under FDA clearance number K103567, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for Class III cardiovascular devices (regulation 870.5310) and is authorized for use in emergency cardiac scenarios as described in its labeling.
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: LIFEPAK 15 V4+ monitor/defibrillator - Stryker, PDF LIFEPAK®15 MONITOR/DEFIBRILLATOR - Stryker Corporation, Physio-Control LifePak 15 Defibrillator/Monitor, Physio Control LIFEPAK 15 Operating Instructions Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103567 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA 510(k) K103567 24 fields · synced Oct 6, 2026