LifePak 250 Defibrillator/Monitor
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K892065 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 250 Defibrillator/Monitor is an automated external defibrillator (non-wearable) designed to deliver synchronized cardioversion and defibrillation shocks to restore normal heart rhythm in patients experiencing life-threatening arrhythmias, such as ventricular fibrillation or pulseless ventricular tachycardia. It also provides real-time ECG monitoring, heart rate analysis, and voice prompts to guide rescuers through resuscitation protocols, including CPR feedback and shock advisory cues.
This Class III device is intended for use in pre-hospital, hospital, and clinical settings, delivering biphasic waveforms for both defibrillation and synchronized cardioversion. Supplied as a reusable medical device, it requires proper calibration, maintenance, and periodic servicing as outlined in the manufacturer’s instructions. The LifePak 250 adheres to FDA clearance under 510(k) K892065, with regulatory compliance governed by 21 CFR 870.5310, and is classified under OpenFDA’s Automated External Defibrillators (Non-Wearable) category. Storage and handling must follow manufacturer guidelines to ensure device reliability and safety.
Frequently asked questions
Is the LifePak 250 Defibrillator/Monitor designed for single-use or reusable applications, and what maintenance does it require?
The LifePak 250 is a reusable medical device, not intended for single-use. It requires proper calibration, maintenance, and periodic servicing as outlined in the manufacturer’s instructions to ensure reliable performance. Regular upkeep is essential to maintain functionality, especially in critical settings like pre-hospital, hospital, or clinical environments.
What types of arrhythmias is the LifePak 250 primarily intended to treat, and how does it guide rescuers during resuscitation?
The LifePak 250 is designed to deliver synchronized cardioversion and defibrillation shocks to restore normal heart rhythm in patients experiencing life-threatening arrhythmias, such as ventricular fibrillation or pulseless ventricular tachycardia. It provides real-time ECG monitoring, heart rate analysis, and voice prompts to guide rescuers through resuscitation protocols, including CPR feedback and shock advisory cues, ensuring structured and informed intervention.
How is the LifePak 250 different from other automated external defibrillators in terms of waveform technology?
The LifePak 250 uses biphasic waveforms for both defibrillation and synchronized cardioversion, which is a key distinction from some other devices that may use monophasic waveforms. Biphasic technology is designed to deliver more controlled energy to the heart, potentially improving effectiveness in restoring normal rhythm while minimizing tissue damage.
What regulatory pathway was followed for FDA clearance of the LifePak 250, and what compliance standards apply?
The LifePak 250 received FDA clearance under a 510(k) submission (K892065) through a traditional review pathway, determined to be substantially equivalent to a predicate device. It complies with 21 CFR 870.5310 and is classified under the OpenFDA Automated External Defibrillators (Non-Wearable) category. Compliance with these standards ensures its safety and performance in pre-hospital, hospital, and clinical settings.
Are there specific storage or handling guidelines for the LifePak 250 to ensure its reliability and safety?
Yes, the LifePak 250 must be stored and handled according to the manufacturer’s guidelines to maintain reliability and safety. While the data does not specify exact storage conditions, adherence to these instructions—likely including environmental controls, protection from physical damage, and proper maintenance protocols—is critical to ensure the device functions correctly when needed 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 | K892065 | Class III | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K892065 24 fields · synced Oct 6, 2026