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Model #225-ST Shock-Trode Adult Defib Pads Sterile

by Cardiotronics, Inc.

510(k) K922227

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 NumberK922227 Date11 Jun 1992ClearedStatusActive

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  • Withdrawn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, 22 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 Model #225-St Shock-Trode Adult Defib Pads Sterile is a Class II cardiac event recorder manufactured by Cardiotronics, Inc. These pads are designed for use with defibrillation devices to deliver electrical shocks to the heart during cardiac emergencies.

The device is supplied sterile and is intended for single-use applications. It received FDA 510(k) clearance on June 11, 1992, with the product code LDD and regulation number 870.5300. The device is classified under the cardiovascular medical specialty and is not indicated for MRI use.

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Questions

AI-generated answers, 22 Sep 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 #225-St Shock-Trode Adult Defib Pads Sterile used for?

    These pads are designed for use with defibrillation devices to deliver electrical shocks to the heart during cardiac emergencies. They are Class II cardiac event recorders manufactured by Cardiotronics, Inc.

  • How are the Model #225-St Shock-Trode Adult Defib Pads supplied?

    The device is supplied sterile and is intended for single-use applications. Each package contains the sterile pads ready for immediate use in emergency cardiac situations.

  • What is the regulatory status of the Model #225-St Shock-Trode Adult Defib Pads?

    The device received FDA 510(k) clearance on June 11, 1992, with product code LDD and regulation number 870.5300. It is classified under the cardiovascular medical specialty and is not indicated for MRI use.

  • Can the Model #225-St Shock-Trode Adult Defib Pads be reused?

    No, these pads are intended for single-use applications only. After use, they should be properly disposed of according to medical waste protocols to ensure safety and prevent cross-contamination.