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Defibtech AED with Attenuated Defibrillation/Monitoring Pads, Models DDU-100 with DDP-200P

by Defibtech, LLC

510(k) K033896

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK033896 Date16 Jun 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2064-2011 FDA Unclassified (pre-2012) initiated 1 Apr 2011

    Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process

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  • Withdrawn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 Defibtech AED with Attenuated Defibrillation/Monitoring Pads (Models DDU-100 with DDP-200P) is a semi-automatic external defibrillator designed to deliver biphasic truncated exponential shocks for the treatment of cardiac arrest. It analyzes heart rhythms and provides voice-guided instructions to assist responders in performing cardiopulmonary resuscitation (CPR) and administering defibrillation when indicated.

This device is supplied as a reusable defibrillator unit paired with single-use attenuated defibrillation/monitoring pads (DDP-200P). It is intended for use in pre-hospital and public access settings, with no specific MRI safety restrictions noted. The pads are stored on the back of the DDU-100 unit and must be replaced after each use. The device holds an FDA 510(k) clearance under the classification of Class III (Automated External Defibrillators, Non-Wearable).

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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.

  • What is the purpose of the Defibtech AED with Attenuated Defibrillation/Monitoring Pads?

    This device is designed to deliver biphasic truncated exponential shocks for treating cardiac arrest. It analyzes heart rhythms and provides voice-guided instructions to assist responders in performing CPR and administering defibrillation when needed.

  • How is the Defibtech AED supplied and what is its reusability?

    The device is supplied as a reusable defibrillator unit paired with single-use attenuated defibrillation/monitoring pads (DDP-200P). The pads must be replaced after each use and are stored on the back of the DDU-100 unit.

  • Are there any MRI safety restrictions for this device?

    No specific MRI safety restrictions are noted for the Defibtech AED with Attenuated Defibrillation/Monitoring Pads, making it suitable for use in various pre-hospital and public access settings.

  • What is the regulatory status of this device?

    The device holds an FDA 510(k) clearance under the classification of Class III (Automated External Defibrillators, Non-Wearable), indicating it has been determined to be substantially equivalent to other devices in this category.