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K-Defib/Pace Pediatric Electrode

by Katecho LLC 510(k)

Active United States

510(k) K954504

Overview

The K-Defib/Pace Pediatric Electrode is a single-use adhesive electrode designed for use with automated external defibrillators (non-wearable) and cardiac pacing devices. It is specifically engineered for pediatric patients, providing precise electrical conduction for defibrillation and pacing procedures in emergency cardiac care settings.

Supplied as a sterile, single-use device, the electrode is intended for pre-hospital and clinical environments where rapid application is critical. It adheres securely to pediatric skin and is compatible with standard defibrillator and pacing systems. The device is classified as Class III under FDA regulations (870.5310) and holds a 510(k) clearance for substantial equivalence in cardiovascular applications. Storage requires protection from moisture and extreme temperatures.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954504 Date17 Nov 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the primary use case for the K-Defib/Pace Pediatric Electrode in emergency settings?

    The K-Defib/Pace Pediatric Electrode is specifically designed for pediatric patients during defibrillation and cardiac pacing procedures in emergency cardiac care. It is engineered to provide precise electrical conduction when used with automated external defibrillators (non-wearable) and cardiac pacing devices, ensuring reliable performance in both pre-hospital and clinical environments where quick application is critical.

  • Is the K-Defib/Pace Pediatric Electrode reusable, or is it intended for single-use only?

    The K-Defib/Pace Pediatric Electrode is explicitly labeled as a single-use device. This design ensures sterility and safety for each application, particularly important in emergency cardiac care where contamination risks must be minimized.

  • How should the K-Defib/Pace Pediatric Electrode be stored to maintain its integrity?

    The electrode must be stored in a dry environment, protected from moisture and extreme temperatures. Proper storage conditions are essential to preserve its adhesive properties and ensure reliable performance when needed in emergency situations.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The K-Defib/Pace Pediatric Electrode received FDA clearance through a 510(k) submission, demonstrating substantial equivalence to a predicate device in cardiovascular applications. It is classified as a Class III device under FDA regulations (870.5310), reflecting its role in life-saving cardiac procedures.

  • Are there different sizes or models available for the K-Defib/Pace Pediatric Electrode?

    The provided data does not specify multiple sizes or models for the K-Defib/Pace Pediatric Electrode. It is designed specifically for pediatric patients, so sizing is likely standardized for this age group. For exact dimensions or variations, refer to the manufacturer’s packaging or technical documentation.