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Defibtech Automated External Defibrillator (AED) Systems

by Defibtech, LLC

PMA P160032

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

9 ongoing

This device is named in the recall

Documents

PMA P160032↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP160032 Date1 Feb 2018ApprovedStatusActive

Recalls

9 recalls · 9 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1691-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1690-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1692-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1693-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1694-2025 FDA Class II initiated 18 Mar 2025

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  • 3 recalls, same reason

    • Ongoing Z-0505-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0504-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0503-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

    • Ongoing Z-0502-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Generic Name
Automated external defibrillators (non-wearable)
PMA Number
FDA Product Code
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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 Automated External Defibrillator (AED) Systems are indicated for use on victims of sudden cardiac arrest who are unconscious, unresponsive, and not breathing or not breathing normally. These devices analyze heart rhythm and deliver a shock if needed to restore normal cardiac function.

The systems are supplied with adult defibrillation pads (model DDP-100 for DDU-100 series, DDP-2001 for DDU-2000 series) and may be used with child/infant pads (model DDP-200 for DDU-100 series, DDP-2002 for DDU-2000 series) for patients under 8 years or under 55 lbs. Authorization is based on FDA PMA approval (P160032) for the Lifeline/ReviveR DDU-100, DDU-120, DDU-2300, DDU-2200, DDU-2450, and DDU-2475 models.

Other devices from Defibtech, LLC

See all devices from Defibtech, LLC →

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 models are included in the Defibtech Automated External Defibrillator (AED) Systems?

    The Defibtech AED Systems include the Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 models, as specified in the approval documentation.

  • Who is the manufacturer of the Defibtech AED Systems?

    The manufacturer of the Defibtech Automated External Defibrillator (AED) Systems is Defibtech, LLC, located in Guilford, Connecticut.

  • What type of authorization does the Defibtech AED System have?

    The Defibtech AED System has FDA Premarket Approval (PMA) authorization, as indicated by the PMA number P160032 and the decision code APPR from February 1, 2018.