Multi-Function Defibrillation Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002079 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Neuroline, Subdermal Needle Electrodes

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• What types of settings can the Multi-Function Defibrillation Electrode be used in, and why is it designed this way?

  The Multi-Function Defibrillation Electrode is designed for use in pre-hospital, clinical, and public access settings, such as ambulances, hospitals, and public spaces like airports or shopping centers. This versatility ensures that emergency responders and healthcare providers can deliver defibrillation treatment wherever cardiac arrest occurs, improving the chances of successful resuscitation. Its compatibility with compatible defibrillators makes it adaptable to various emergency scenarios.

• Are the electrodes reusable, and if not, why is single-use recommended?

  No, the Multi-Function Defibrillation Electrode is explicitly intended for single-use only and is not reusable. This design choice is likely due to concerns about maintaining sterility, hygiene, and reliability after repeated use, which could compromise patient safety during critical cardiac emergencies. Single-use electrodes also reduce the risk of cross-contamination and ensure consistent performance.

• How should the electrodes be stored to maintain their integrity, and why is this important?

  The electrodes must be stored according to the manufacturer’s guidelines to preserve their sterility and functionality. Since they are packaged sterile for immediate clinical use, improper storage—such as exposure to moisture, extreme temperatures, or physical damage—could compromise their integrity. Proper storage ensures the electrodes remain ready for use in emergencies without risking contamination or degradation.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for users?

  The Multi-Function Defibrillation Electrode received FDA clearance through a 510(k) submission, specifically under regulation number 870.5310, and was determined to be substantially equivalent to a predicate device. This means the FDA reviewed it against an existing, legally marketed device and concluded it has the same intended use and technological characteristics. For users, this indicates the device meets FDA safety and effectiveness standards, though it does not imply approval for specific clinical indications—only that it adheres to regulatory requirements for defibrillation electrodes.