Bio-Detek Modified Adult Multi-Function Electrode with Connector

• • Terminated Z-2565-2014 FDA Class II ·initiated 12 Mar 2013

  Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

510(k) Number

K033771 ↗

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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See all devices from Bio-Detek, Inc. →

• What is the primary use case for the BIO-DETEK Modified Adult Multi-Function Electrode with Connector, and where would it typically be deployed?

  The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is designed specifically for delivering electrical shocks during cardiac defibrillation to restore a normal heart rhythm. It is intended for single-use in emergency cardiac care settings, making it suitable for both pre-hospital environments (e.g., ambulances) and clinical environments (e.g., hospitals, emergency rooms). Its multi-function design ensures precise application and compatibility with standard defibrillator systems.

• Is this electrode reusable, or is it meant for one-time use? How does this affect its handling and storage?

  This electrode is explicitly designed for single-use only, which means it should not be reused after a single application. This design choice ensures patient safety and sterility, as it is supplied sterile and packaged for immediate use. Because of this, proper handling and storage are critical—it must be kept protected from contamination and physical damage until use, but no special storage conditions (like refrigeration) are required.

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

  The BIO-DETEK Modified Adult Multi-Function Electrode with Connector received FDA 510(k) clearance under the Traditional pathway, classified as a Class III device under regulation 870.5310 (Automated External Defibrillators, Non-Wearable). This classification reflects its role in life-saving cardiac interventions, requiring rigorous review by the Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness. The clearance confirms it is substantially equivalent to predicate devices already on the market.

• How do I know if this electrode is compatible with my defibrillator system, and are there any special storage instructions?

  This electrode is designed for compatibility with standard defibrillator systems, meaning it should work with most automated external defibrillators (AEDs) in clinical or pre-hospital use. No special storage conditions are required beyond protecting it from contamination and physical damage—it does not need refrigeration or humidity-controlled environments. Always verify compatibility with your specific defibrillator model before use, though the multi-function design suggests broad applicability.