Disposable Hydrogel Defibrillation Electrode/Pad

• • Terminated Z-2547-2015 FDA Class II ·initiated 19 Aug 2015

  Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns

510(k) Number

K960329 ↗

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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  FDA 510(k) K952804 Active Cleared 4 Apr 1996

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  FDA 510(k) K970391 Active Cleared 6 Mar 1997

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  FDA 510(k) K952805 Active Cleared 4 Apr 1996

• Noah Monitoring Electrode System

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  FDA 510(k) K970125 Active Cleared 4 Mar 1997

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  FDA 510(k) K952807 Active Cleared 4 Apr 1996

• Temperature PROBE-TP350

  Class II

  FDA 510(k) K952803 Active Cleared 4 Apr 1996

See all devices from Contour Medical Technology, Inc. →

• Are these electrodes reusable or designed for single-use only, and why does that matter in an emergency setting?

  These electrodes are explicitly designed for single-use only, as stated in the description. This is critical in emergency settings because single-use devices eliminate the risk of cross-contamination between patients, ensuring sterility and reducing infection risks during life-threatening cardiac events. Reusing them could compromise patient safety and violate manufacturer guidelines.

• What sizes or configurations are available, and how do I ensure compatibility with my automated external defibrillator (AED)?

  The device is described as having standardized sizes and configurations specifically for compatibility with automated external defibrillators. While exact dimensions or model-specific variants aren’t detailed, the FDA clearance under the Automated External Defibrillators (Non-Wearable) category (product code MKJ) confirms it’s designed to fit common AED systems. Always verify compatibility with your AED’s manufacturer instructions or user manual before use.

• How should I store these electrodes, and what precautions should I take to maintain their sterility?

  The electrodes are sterile and individually packaged for single-use. Storage should follow the manufacturer’s guidelines (not explicitly detailed here), but generally, they should be kept in a cool, dry place away from direct sunlight to preserve integrity. Avoid exposing them to extreme temperatures or moisture, as this could compromise sterility or adhesive properties. Always check the packaging for damage before use.

• What does the FDA clearance under classification III mean for this device, and how does it differ from other defibrillation electrodes?

  The FDA 510(k) clearance under classification III indicates this device is regulated as a high-risk medical product, requiring rigorous premarket review to ensure safety and effectiveness. Unlike lower-risk devices (e.g., Class I or II), Class III clearance involves substantial evidence of performance, including clinical data, to demonstrate safety and efficacy. This classification is common for life-saving devices like defibrillation electrodes, where failure could result in severe harm.

• Can these electrodes be used with MRI machines, or are there any safety restrictions I should know about?

  The device description explicitly states no MRI safety restrictions are specified, meaning there’s no documented evidence to suggest these electrodes are safe for use in MRI environments. However, this doesn’t imply they *are* MRI-compatible—only that their safety in such settings hasn’t been evaluated or restricted. Always consult your MRI facility’s protocols and the electrode manufacturer for guidance before use in an MRI setting.