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Infant/Child Reduced Energy Electrodes

by Medtronic Physio-Control Corp.

510(k) K022732

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK022732 Date13 Dec 2002ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2360-2020 FDA Class II initiated 24 Apr 2020
    • Terminated Z-2359-2020 FDA Class II initiated 24 Apr 2020

    Packaging of infant child reduced energy electrodes was not properly sealed.

  • 2 recalls, same reason

    • Terminated Z-0186-2018 FDA Class I initiated 27 Oct 2017
    • Terminated Z-0187-2018 FDA Class I initiated 27 Oct 2017

    The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

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  • Withdrawn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 Infant/Child Reduced Energy Electrodes are adhesive electrodes designed for use with automated external defibrillators (non-wearable). These electrodes are specifically engineered to deliver reduced energy levels, ensuring safety and efficacy for pediatric patients during defibrillation procedures. Their design aligns with cardiovascular applications, providing a tailored solution for infants and children requiring defibrillation support.

These electrodes are intended for single-use and are supplied sterile, ensuring compliance with clinical standards for patient safety. They are classified as Class III medical devices under FDA regulations and are authorized through a 510(k) clearance. The electrodes are compatible with automated external defibrillators and are supplied in a ready-to-use format, requiring no additional preparation beyond proper application to the patient’s chest. Storage should adhere to manufacturer guidelines to maintain sterility and functionality.

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