LifePak 15 Monitor/Defibrillator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K082937 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 electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It combines real-time cardiac monitoring with automated defibrillation, enabling rapid assessment and intervention during emergencies. The device is intended for use by trained responders, including healthcare professionals and lay rescuers, in both pre-hospital and in-hospital settings.
Supplied as a reusable medical device, the LifePak 15 is intended for use in environments where electrical safety standards are maintained. It operates on standard power sources and includes features for MRI safety compliance where applicable. The device is regulated under FDA 510(k) clearance (K082937) and falls under Device Class III per FDA classification. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility where applicable, though it is not a single-use device.
Frequently asked questions
Is the LifePak 15 Monitor/Defibrillator intended for single-use or reusable in clinical settings?
The LifePak 15 is designed as a reusable medical device. It is not intended for single-use, and its functionality relies on proper maintenance and storage as outlined by the manufacturer to ensure reliability in both pre-hospital and in-hospital environments.
What types of environments is the LifePak 15 Monitor/Defibrillator approved for use in?
The device is intended for use by trained responders, including healthcare professionals and lay rescuers, in both pre-hospital and in-hospital settings. It is also designed to comply with electrical safety standards and includes features for MRI safety where applicable.
How is the LifePak 15 powered, and does it require any special electrical infrastructure?
The LifePak 15 operates on standard power sources, meaning it can be plugged into typical electrical outlets without requiring specialized infrastructure. This makes it versatile for use in various clinical and emergency settings.
What regulatory pathway was followed for the FDA clearance of the LifePak 15?
The LifePak 15 received FDA 510(k) clearance under the classification of Device Class III, with a decision date of March 11, 2009. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device.
Does the LifePak 15 require any special handling or storage conditions to maintain its functionality?
While the device itself is not sterile (as it is reusable), proper storage and maintenance per manufacturer guidelines are essential to ensure its functionality. This includes adhering to electrical safety protocols and periodic servicing to guarantee reliable performance in emergency situations.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082937 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA 510(k) K082937 24 fields · synced Oct 6, 2026