Zoll E Series Defibrillator

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

510(k) Number

K072923 ↗

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 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 →

• Is the Zoll E Series Defibrillator designed for single-use or repeated use in clinical settings? Why does this matter?

  The Zoll E Series Defibrillator is a reusable device, not intended for single-use. This matters because reusable defibrillators require proper maintenance, calibration, and storage to ensure reliability and safety over multiple uses, as outlined in the manufacturer’s guidelines and compliance with 21 CFR Part 870.5310 standards.

• What types of environments is the Zoll E Series Defibrillator intended for, and why is electrical safety emphasized?

  The Zoll E Series Defibrillator is designed for prehospital and clinical settings, including emergency response and cardiac care environments where electrical safety and reliability are critical. Electrical safety is emphasized because it delivers high-energy shocks, requiring a durable, non-single-use device to minimize risks of malfunction or failure during critical interventions.

• How does the Zoll E Series Defibrillator combine automated and manual capabilities, and why is this feature important?

  The Zoll E Series Defibrillator combines automated rhythm analysis with manual override capabilities, allowing for rapid defibrillation while also giving trained responders control when needed. This dual functionality ensures both speed in emergencies and precision in treatment, improving outcomes in sudden cardiac arrest scenarios.

• What regulatory classification does the Zoll E Series Defibrillator fall under, and what does this mean for its use?

  The Zoll E Series Defibrillator is classified under Class III by the FDA, which means it is subject to stringent regulatory oversight due to its high-risk nature. This classification ensures rigorous pre-market review (via 510(k) clearance) and ongoing compliance to maintain safety and effectiveness in treating sudden cardiac arrest.

• What maintenance or storage requirements should be followed to keep the Zoll E Series Defibrillator functional and compliant?

  The Zoll E Series Defibrillator requires regular maintenance, calibration, and storage per manufacturer guidelines to ensure proper functionality and compliance with 21 CFR Part 870.5310. Since it is reusable, adherence to these protocols is essential to prevent malfunctions, especially in high-stakes environments like emergency response or cardiac care.