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LifePak 12 Biphasic

FDA 510(k)

Class III (US FDA 510(k))

510(k) K991910

by Physio-Control Corp.

Identifiers

510(k) Number
K991910 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
ST FDA 510(k)

The LifePak 12 Biphasic is an Automated External Defibrillator (Non-Wearable), designed to deliver biphasic waveform shocks for the treatment of cardiac arrest. It provides automated rhythm analysis and defibrillation therapy, along with ECG monitoring to support resuscitation efforts in both adult and pediatric patients.

This device is intended for use in emergency and pre-hospital settings, where trained responders administer defibrillation and monitor cardiac activity. Supplied as a reusable medical device, it requires proper maintenance and calibration as outlined in its service manual. The LifePak 12 Biphasic holds an FDA 510(k) clearance under the classification of Class III, with regulatory tracking under the device code MKJ and regulation number 870.5310.

Frequently asked questions

What types of patients can the LifePak 12 Biphasic be used on, and where is it typically deployed?

The LifePak 12 Biphasic is designed for both adult and pediatric patients experiencing cardiac arrest, delivering biphasic waveform shocks for defibrillation. It is primarily intended for emergency and pre-hospital settings, such as ambulances, fire stations, and other first-response environments where trained responders administer defibrillation and monitor cardiac activity.

Is the LifePak 12 Biphasic a single-use or reusable device, and what maintenance does it require?

The LifePak 12 Biphasic is a reusable medical device, meaning it is built for repeated use in clinical settings. Like all reusable devices, it requires regular maintenance and calibration as outlined in its service manual to ensure proper functionality and safety during resuscitation efforts.

How is the regulatory status of the LifePak 12 Biphasic determined, and what does that mean for buyers?

The LifePak 12 Biphasic holds an FDA 510(k) clearance under the classification of Class III, with regulatory tracking under the device code MKJ and regulation number 870.5310. This means the device was reviewed by the FDA’s Cardiovascular (CV) advisory committee and deemed substantially equivalent to a legally marketed predicate device, allowing it to enter the market with specific tracking requirements for post-market surveillance.

What features does the LifePak 12 Biphasic include beyond just defibrillation?

Beyond delivering biphasic waveform shocks for defibrillation, the LifePak 12 Biphasic provides automated rhythm analysis to assess cardiac activity and ECG monitoring to support resuscitation efforts. These features help responders quickly determine if a shock is needed and continuously track the patient’s heart rhythm during treatment.

What should buyers consider regarding the device’s supply chain or availability?

The LifePak 12 Biphasic is manufactured by Physio-Control Corp. and is distributed through authorized medical supply channels. Buyers should confirm availability through their preferred distributor or directly with Physio-Control, as supply may vary by region. Since it is reusable, maintenance contracts and spare parts (such as batteries, pads, and cables) should also be factored into procurement planning.

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: PDF LIFEPAKfi 12 defibrillator/monitor series Service Manual, Medtronic Physio-Control Lifepak 12 Service Manual, PDF LIFEPAK® 12 3D BIPHASIC - Outfront Medical, Medtronics (Physio Control) Lifepak 12 Biphasic Defibrillator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K991910 24 fields · synced Sep 18, 2026