Zoll R Series

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

510(k) Number

K120907 ↗

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

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• What environments is the Zoll R Series intended for use in and how does its design support rapid response in emergencies?

  The Zoll R Series is designed for use in emergency medical services, public access defibrillation programs, and clinical environments where sudden cardiac arrest may occur. Its automated and manual modes allow for quick assessment of heart rhythm and immediate delivery of defibrillation therapy, prioritizing rapid response in out-of-hospital and pre-hospital settings.

• Is the Zoll R Series a single-use device, or is it meant for repeated use? What maintenance is required?

  The Zoll R Series is a reusable device and not intended for single-use. It requires regular maintenance as outlined by the manufacturer to ensure proper functionality and reliability over time.

• What regulatory pathway was followed for the Zoll R Series, and what classification does it hold?

  The Zoll R Series followed the FDA 510(k) clearance pathway, specifically with clearance number K120907. It is classified under device class 3, regulated under the FDA’s regulation number 870.5310, which pertains to automated external defibrillators.

• Does the Zoll R Series have any specific safety considerations for use in environments with MRI equipment?

  The provided data does not mention any specific MRI safety classification for the Zoll R Series, meaning its compatibility or safety in MRI environments is not detailed. Users should consult manufacturer guidelines for proper handling and storage if MRI exposure is a concern.