Zoll E Series

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

510(k) Number

K133239 ↗

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 →

• What types of environments is the Zoll E Series Automated External Defibrillator intended for use in, and who should operate it?

  The Zoll E Series is designed for use in both pre-hospital and in-hospital settings, such as emergency rooms, ambulances, and public access defibrillation programs. It is intended for trained responders who require defibrillation capabilities to analyze heart rhythms and administer electrical shocks when sudden cardiac arrest occurs.

• Is the Zoll E Series a single-use device, or can it be reused? If reusable, what maintenance is required?

  The Zoll E Series is a reusable device, not intended for single-use. Proper storage and maintenance must follow the manufacturer’s guidelines to ensure functionality and compliance with regulatory standards, as outlined in the device’s instructions.

• What regulatory pathway was followed for the Zoll E Series, and what does this mean for its use?

  The Zoll E Series was authorized through the FDA’s 510(k) clearance process, specifically under K133239, as substantially equivalent to predicate devices. This means it meets FDA standards for safety and effectiveness as a Class III medical device, ensuring it can be legally used for its intended purpose in the U.S.

• Does the Zoll E Series comply with MRI safety guidelines, and if so, where can it be used?

  Yes, the Zoll E Series operates within MRI safety guidelines for non-MRI environments. This means it can be safely used in areas where MRI machines are present, provided it is not inside the MRI scanner itself.