Zoll E Series with SPCO/SPMet Option

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

510(k) Number

K092598 ↗

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 settings is the Zoll E Series with SPCO/SPMet Option intended for use in, and who can operate it?

  The Zoll E Series with SPCO/SPMet Option is designed for use in both pre-hospital (e.g., emergency medical services) and in-hospital settings. It is intended for trained responders, including EMS personnel and healthcare professionals, who have received proper training in defibrillation and resuscitation procedures.

• Is the Zoll E Series reusable, and what maintenance does it require?

  Yes, the Zoll E Series is a reusable device. To ensure reliable performance, it requires regular maintenance and calibration as specified by Zoll Medical Corporation. This includes periodic inspections, cleaning, and servicing to meet the manufacturer’s guidelines for safe and effective operation.

• What advanced features does the Zoll E Series offer beyond basic defibrillation?

  Beyond delivering life-saving electrical shocks, the Zoll E Series includes advanced monitoring features such as electrocardiogram (ECG) analysis and voice prompts. These features guide responders through resuscitation procedures, providing real-time feedback and step-by-step instructions to improve patient outcomes during sudden cardiac arrest.

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

  The Zoll E Series with SPCO/SPMet Option underwent a traditional 510(k) clearance process through the FDA, classified under the Cardiovascular advisory committee. This means the device was deemed *substantially equivalent* to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for automated external defibrillators. The classification as Class III reflects its critical role in emergency cardiac care, requiring rigorous validation.