Zoll Fully Automatic AED Plus

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

510(k) Number

K120406 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Propaq MD

  Class III

  FDA 510(k) K112761 Active Cleared 25 Apr 2012

• Zoll Propaq Md

  Class II

  FDA 510(k) K102468 Active Cleared 30 Sep 2010

• Zoll E Series with CPRReadyCharge

  Class III

  FDA 510(k) K091265 Active Cleared 23 Dec 2009

• Zoll E Series Defibrillator

  Class III

  FDA 510(k) K072923 Active Cleared 24 Apr 2008

• Zoll E Series with Bluetooth Dial Up Networking

  Class III

  FDA 510(k) K081081 Active Cleared 9 Mar 2009

• Zoll R Series with 2010 Aha Guidelines Software Update

  Class III

  FDA 510(k) K110361 Active Cleared 8 Mar 2011

See all devices from Zoll Medical Corporation, World Wide Headquarters →

• Is this AED designed for use by healthcare professionals only, or can untrained responders operate it as well?

  The Zoll Fully Automatic AED Plus is explicitly designed for use by both trained and untrained responders in cardiac arrest emergencies. Its fully automatic mode eliminates the need for manual intervention, making it accessible for individuals without advanced medical training.

• How should I store this device to ensure proper functionality and longevity?

  The device requires storage in a dry, temperature-controlled environment. Since it is not MRI-safe, it should also be kept away from magnetic fields. Proper storage conditions help maintain its performance and reliability for emergency use.

• Can this AED be reused, or is it intended for single-use only?

  The Zoll Fully Automatic AED Plus is supplied for either single-use or reusable applications, depending on local protocols and maintenance cycles. Reuse requires adherence to established cleaning and servicing guidelines to ensure safety and functionality.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  The Zoll Fully Automatic AED Plus was authorized through the FDA’s 510(k) clearance process (K120406) and is classified as a Class III medical device. This classification aligns with its role in cardiovascular resuscitation, reflecting its critical role in emergency cardiac care.