LifePak 15 Monitor/Defibrillator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K142430 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 for emergency cardiac resuscitation. It delivers manual and semiautomatic defibrillation, noninvasive pacing, and advanced monitoring capabilities, including 12-lead ECG, noninvasive blood pressure, and optional oximetry and CO₂ monitoring.
Supplied as a reusable Class III device, the LifePak 15 is intended for use in prehospital, hospital, and clinical settings. It features substantial memory and data storage for clinical documentation and remote transmission. Authorized under FDA 510(k) clearance (K142430), it adheres to regulatory standards for cardiovascular devices and is distributed by Physio-Control, Inc.
Frequently asked questions
What types of defibrillation and monitoring capabilities does the LifePak 15 offer, and how does it differ from standard AEDs?
The LifePak 15 provides both manual and semiautomatic defibrillation, which allows clinicians to override the device’s automated shock advice when needed. Unlike basic automated external defibrillators (AEDs), it also includes advanced monitoring features such as 12-lead ECG, noninvasive blood pressure measurement, and optional oximetry and CO₂ monitoring. This makes it suitable for prehospital, hospital, and clinical settings where detailed cardiac assessment is required beyond shock delivery alone.
Is the LifePak 15 designed for single-use or reusable applications, and what does this mean for maintenance?
The LifePak 15 is a reusable Class III device, meaning it is built for repeated use in clinical environments. This design requires regular maintenance, calibration, and cleaning as specified by the manufacturer to ensure reliable performance. Reusability also means it can be shared across multiple patients, provided proper infection control protocols are followed.
What storage or environmental conditions are recommended for the LifePak 15 to ensure proper functionality?
While the device data does not specify exact storage conditions, reusable medical devices like the LifePak 15 typically require protection from extreme temperatures, humidity, and direct sunlight. The manufacturer’s instructions (not detailed here) would outline ideal storage environments to maintain device integrity, battery life, and operational readiness for emergency use.
How does the LifePak 15 support clinical documentation and data sharing compared to other defibrillators?
The LifePak 15 features substantial memory and data storage capabilities, allowing it to record detailed clinical information during resuscitation efforts. This includes ECG tracings, defibrillation events, and other monitoring data. The device is designed to enable remote transmission of this data, which can be critical for post-event review, quality improvement, and communication with healthcare teams or emergency response systems.
What regulatory pathway was followed for the FDA clearance of the LifePak 15, and what does this imply for its use?
The LifePak 15 received FDA clearance through a 510(k) traditional review process, specifically under K142430, and was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates the device meets FDA standards for safety and effectiveness as an automated external defibrillator (non-wearable) and is authorized for use in prehospital, hospital, and clinical settings as described in its labeling. The Cardiovascular (CV) advisory committee reviewed the submission, ensuring compliance with cardiovascular device regulations.
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 | K142430 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA 510(k) K142430 24 fields · synced Oct 6, 2026