Zoll AED Pro External Defibrillator

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Model / reference

90210400499991020, 90210200499991050, 90210200499991220, 90210200499991090

Primary DI / UDI-DI

00847946097493, 00847946000158, 00847946097196, 00847946097097

Basic UDI-DI

B-00847946097493, B-00847946000158, B-00847946097196, B-00847946097097

510(k) Number

K041892 ↗

FDA product code

MKJ

EMDN code

Z12030501 Semi-automatic defibrillators

Device class

Class IIb EUDAMED

Class III 510(k)

Regulation

21 CFR Part 870.5310

EU registration type

Legacy device (under a directive)

EU market of registration

Netherlands

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

• 8900-0400

  Class I

  CE/MDR

• R Series

  Class IIb

  CE/MDD

• Onestep Cpr Adult Electrodes

  Class I

  CE/MDR

• 731 Ventilator

  Class IIb

  CE/MDD

• Zenix 1116-111075-21-Usa-0

  Class III

  GUDID on market

• Radiotransparent Defibrillation Electrode 8900-004041-01

  Class III

  GUDID on market

See all devices from Zoll Medical Corporation →

• Is the Zoll AED Pro designed for reuse in multiple cardiac emergencies, or is it intended for single-use only?

  The Zoll AED Pro is explicitly designed for single-use only, meaning it is not intended to be reused after a single cardiac emergency event. This aligns with its classification as a portable, non-reusable unit for emergency use in pre-hospital and public access settings.

• How should the Zoll AED Pro be stored to maintain its functionality and safety?

  The device must be stored in a dry, temperature-controlled environment as specified by the manufacturer. This ensures optimal performance and longevity, particularly since it is intended for emergency use where reliability is critical.

• What type of regulatory clearance does the Zoll AED Pro hold, and how does this affect its use?

  The Zoll AED Pro holds FDA 510(k) clearance, meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. It also complies with the Medical Device Directive (MDD), ensuring regulatory adherence for use in cardiac resuscitation scenarios in both the U.S. and EU markets.

• Can the Zoll AED Pro be used in an MRI environment, or is it safe to keep near MRI machines?

  The Zoll AED Pro is not MRI-compatible, meaning it should never be placed in or near an MRI environment. This is explicitly noted in the device’s specifications, as electromagnetic interference or damage from MRI fields could compromise its functionality or safety.

• What kind of guidance does the Zoll AED Pro provide to users during an emergency, and is it suitable for untrained responders?

  The Zoll AED Pro provides voice prompts and visual guidance to assist users in performing CPR and defibrillation. This feature is specifically designed to support untrained responders, ensuring they can follow clear instructions during a cardiac emergency without prior medical training.