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Multifunctional Electrode Models 9640, 9650

FDA 510(k)

Class III (US FDA 510(k))

510(k) K022210

by Cardiac Science Corporation

Identifiers

510(k) Number
K022210 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 Multifunctional Electrode Models 9640 and 9650 are reusable adhesive electrodes designed for use with automated external defibrillators (non-wearable). These electrodes facilitate cardiac rhythm analysis and deliver defibrillation shocks during emergency cardiac events, ensuring proper electrical connection between the device and the patient’s chest.

Supplied as reusable components, these electrodes are intended for use in emergency medical settings, including pre-hospital and in-hospital environments. They are classified as Class III devices under FDA regulations (870.5310) and require compliance with defibrillator system standards. The electrodes are not sterile and must be cleaned and inspected between uses to maintain performance and safety. No specific MRI safety information is provided.

Frequently asked questions

Are these electrodes suitable for use in both pre-hospital and hospital settings, and if so, what makes them appropriate for emergency use?

Yes, the Multifunctional Electrode Models 9640 and 9650 are designed for use in both pre-hospital and in-hospital emergency settings. Their reusable adhesive design ensures reliability during critical cardiac events, facilitating cardiac rhythm analysis and delivering defibrillation shocks as part of automated external defibrillator (non-wearable) systems. Their durability and compliance with defibrillator system standards make them suitable for high-stakes environments where immediate, accurate electrical connection is essential.

How should these electrodes be prepared and maintained between uses, given they are reusable?

Since these electrodes are reusable, they must be thoroughly cleaned and inspected between each use to maintain performance and safety. The manufacturer does not state they are sterile, so proper disinfection protocols should be followed to prevent contamination. Regular inspection ensures the adhesive and conductive properties remain intact for reliable cardiac rhythm analysis and defibrillation.

What regulatory pathway was followed for clearance of these electrodes, and what does that mean for their use in clinical settings?

The Multifunctional Electrode Models 9640 and 9650 underwent a traditional 510(k) clearance process through the FDA, classified under the Cardiovascular advisory committee (CV) and assigned product code MKJ. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for use with automated external defibrillators (non-wearable) in emergency cardiac care.

Are these electrodes compatible with any specific types of automated external defibrillators, or are they designed to work broadly across systems?

The electrodes are designed to work with automated external defibrillators (non-wearable) systems broadly, as indicated by their classification under FDA product code MKJ and their role in facilitating cardiac rhythm analysis and delivering defibrillation shocks. While compatibility may vary by manufacturer, their multifunctional design suggests they are intended for use with a range of compatible defibrillator systems in emergency settings.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K022210 24 fields · synced Sep 18, 2026