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Model #100 Shock-Trode Child Defib Pads

by Cardiotronics, Inc.

510(k) K911455

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 NumberK911455 Date16 Oct 1991ClearedStatusActive

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  • Withdrawn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
LDD
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Model #100 Shock-Trode Child Defib Pads is a low-energy defibrillator device, specifically designed as paddles for use in cardiac defibrillation. It is classified as a Class II medical device under the cardiovascular specialty, with FDA 510(k) clearance under product code LDD and regulation number 870.5300.

The device was cleared by the FDA through a traditional 510(k) process, with K-number K911455, and received clearance on October 16, 1991. It is manufactured by Cardiotronics, Inc., and is intended for use in cardiovascular applications as a substantially equivalent device to a legally marketed predicate.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Model #100 Shock-Trode Child Defib Pads used for?

    The Model #100 Shock-Trode Child Defib Pads is a low-energy defibrillator device specifically designed as paddles for use in cardiac defibrillation procedures for pediatric patients. It is intended for cardiovascular applications.

  • What is the regulatory status of this device?

    The device is classified as a Class II medical device under the cardiovascular specialty, with FDA 510(k) clearance under product code LDD and regulation number 870.5300. It received clearance through a traditional 510(k) process with K-number K911455 on October 16, 1991.

  • Is this device single-use or reusable?

    The device data does not specify whether the Model #100 Shock-Trode Child Defib Pads is designed for single-use or multiple reuse. For proper usage instructions, please refer to the manufacturer's guidelines or contact Cardiotronics, Inc. directly.

  • What sizes and models of this device are available?

    The device data only mentions the Model #100 Shock-Trode Child Defib Pads, with no information about different sizes or models. For specific sizing options or additional models, please contact the manufacturer Cardiotronics, Inc. directly.