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Marquette Defib Electrodes

by Marquette Electronics, Inc.

510(k) K952101

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952101 Date7 Sep 1995ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Marquette Defib Electrodes are adhesive pads designed for use with automated external defibrillators (non-wearable). These electrodes deliver electrical shocks to the heart during cardiac arrest to restore normal rhythm, serving as a critical component in emergency resuscitation.

These electrodes are intended for single-use and are supplied sterile in sealed packaging. They are classified as Class III medical devices under FDA regulations (21 CFR 870.5310) and were granted 510(k) clearance (K952101) in 1995. Compatible with Marquette Electronics’ defibrillator systems, they require no additional preparation beyond proper application to the patient’s chest.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these electrodes reusable or designed for single-use only, and what does that mean for my workflow?

    The Marquette Defib Electrodes are explicitly designed for single-use only, meaning each pair is intended for one patient encounter. This ensures sterility and reduces the risk of cross-contamination. Since they come sterile in sealed packaging, you won’t need to clean or reprocess them between uses, simplifying your emergency response workflow.

  • What defibrillator systems are these electrodes compatible with, and do I need any special preparation before use?

    These electrodes are specifically designed for compatibility with Marquette Electronics’ defibrillator systems only. No additional preparation is required beyond proper application to the patient’s chest—just peel and stick as per the manufacturer’s instructions for optimal performance during resuscitation.

  • How should I store these electrodes to maintain their sterility and functionality?

    The electrodes are supplied sterile in sealed packaging, so they should be stored in their original, unopened packaging to preserve sterility. Keep them in a cool, dry place away from direct sunlight or extreme temperatures, as recommended for most single-use medical adhesives. Avoid exposing them to moisture or contamination before use.

  • Are there different sizes or models available, and how do I know which one to choose for a patient?

    The provided data does not specify multiple sizes or models for the Marquette Defib Electrodes. Since they are designed for adult use with automated external defibrillators (non-wearable), they should be appropriate for standard adult chest sizes. Always follow the manufacturer’s guidelines for proper placement and ensure the electrodes are applied correctly for effective shock delivery.