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AED 3, AED Plus

by Zoll Medical Corporation

PMA P160015510(k) K033474

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP160015 Date26 May 2017ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK033474 Date21 May 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1206-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009

    Device fails to discharge the defibrillation energy.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Trade name
AED Plus and Fully Automatic AED Plus
Generic name
Automated external defibrillators (non-wearable)
FDA applicant
Zoll Medical Corp
PMA number
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 Zoll AED Plus and Fully Automatic AED Plus are non-wearable automated external defibrillators designed to treat victims of suspected cardiac arrest. These devices are indicated for use when a patient exhibits an apparent lack of circulation, characterized by unconsciousness, absence of normal breathing, and an absence of a pulse or signs of circulation.

These devices are intended for use by personnel trained in basic life support, advanced life support, or a physician-authorized emergency medical response program. When treating a patient under 8 years of age or weighing less than 55 lbs (25kg), the devices must be used with the appropriate pediatric electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

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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.

  • Who is authorized to operate the Zoll AED Plus?

    The device is intended for use by individuals who have received formal training in basic life support, advanced life support, or a physician-authorized emergency medical response program.

  • Can the AED Plus be used on children?

    Yes, the device can be used on children under 8 years of age or weighing less than 55 lbs (25kg), provided that the specific Zoll AED Plus Pediatric Electrodes are used.

  • What are the clinical indications for using this defibrillator?

    The device is indicated for use on victims of suspected cardiac arrest who show signs of unconsciousness, lack of normal breathing, and an absence of a pulse or other signs of circulation.