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Shock Advisory Adapter For Use W/Lifepak 9

FDA 510(k)

Class III (US FDA 510(k))

510(k) K892005

by Physio-Control Corp.

Identifiers

510(k) Number
K892005 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 Shock Advisory Adapter for Use with LifePak 9 is a device designed as an accessory for automated external defibrillators (non-wearable). It interfaces with the LifePak 9 defibrillator to provide advisory shock timing signals, enhancing the device’s ability to deliver synchronized defibrillation therapy during cardiac arrest emergencies.

This adapter is intended for single-use in clinical and pre-hospital settings, including emergency rooms, ambulances, and public access defibrillation programs. Supplied sterile and packaged individually, it requires no additional sterilization. The device is classified as Class III under FDA regulations and is authorized for use with the LifePak 9 defibrillator system. No MRI safety information is specified, and the product code assigned is MKJ.

Frequently asked questions

Is this adapter reusable or intended for single-use only in emergency settings?

The Shock Advisory Adapter for LifePak 9 is explicitly designed for single-use only, as stated in the description. It is supplied sterile and packaged individually, eliminating the need for additional sterilization before use in clinical or pre-hospital environments like emergency rooms, ambulances, or public access defibrillation programs.

How does this adapter enhance the functionality of the LifePak 9 defibrillator?

The adapter interfaces with the LifePak 9 defibrillator to provide advisory shock timing signals, which improve the device’s ability to deliver synchronized defibrillation therapy during cardiac arrest emergencies. This helps clinicians or first responders deliver more precise and effective treatment during critical moments.

What storage or handling precautions should be taken with this single-use device?

Since the adapter is sterile and individually packaged, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity. The packaging should remain unopened until immediate use, as it is not designed for reuse or reprocessing.

Is this adapter compatible with any other defibrillator besides the LifePak 9?

The description specifies that this adapter is intended exclusively for use with the LifePak 9 defibrillator system. It is not designed or approved for compatibility with other defibrillator models, so verification of compatibility with the specific LifePak 9 model in use is essential.

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: Shock Advisory Adapter for Use W/Lifepak 9, K892005 FDA 510(k) - SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9, PHYSIO CONTROL Lifepak 9 Shock advisory adapter, Shock Advisory Adapter for Use W/Lifepak 9, SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 - fda.report

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) K892005 24 fields · synced Sep 18, 2026