Zoll E Series with CPRReadyCharge

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

510(k) Number

K091265 ↗

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 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

• Zoll E Series with 2010 Aha Guidlines Software Update

  Class III

  FDA 510(k) K110168 Active Cleared 17 Feb 2011

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

• What types of environments is the Zoll E Series with CPRReadyCharge intended for use in, and who can operate it?

  The Zoll E Series with CPRReadyCharge is designed for use in pre-hospital, in-hospital, and public-access settings, where both trained responders and laypersons may administer care during sudden cardiac arrest. Its CPR feedback feature helps optimize chest compression quality, making it suitable for emergency scenarios where quick, effective intervention is critical.

• Is the Zoll E Series with CPRReadyCharge a single-use or reusable device, and what maintenance does it require?

  The Zoll E Series with CPRReadyCharge is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance according to the manufacturer’s guidelines. Reusability ensures long-term availability in emergency settings but requires adherence to Zoll’s maintenance protocols to ensure reliability and safety.

• Does the Zoll E Series with CPRReadyCharge include any additional features beyond defibrillation, and how do they enhance resuscitation efforts?

  Yes, the Zoll E Series with CPRReadyCharge combines defibrillation capabilities with real-time CPR feedback. This feature analyzes chest compression quality during resuscitation, providing audio and visual guidance to improve compression depth, rate, and relaxation time—critical factors that significantly impact survival outcomes in cardiac arrest scenarios.

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

  The Zoll E Series with CPRReadyCharge follows the FDA’s Traditional 510(k) pathway, achieving substantial equivalence (SESE) in cardiovascular applications. It is classified as a Class III device under FDA regulations (870.5310), reflecting its role in life-saving interventions for sudden cardiac arrest. The clearance number is K091265.