Zoll X Series

• • Terminated Z-1311-2014 FDA Class II ·initiated 5 Mar 2014

  Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

• • Terminated Z-2401-2012 FDA Class II ·initiated 16 Aug 2012

  Shipped with incorrect software

510(k) Number

K112432 ↗

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 →

• Is the Zoll X Series designed for single-use or can it be reused in multiple cardiac emergencies?

  The Zoll X Series is explicitly described as a reusable medical device, meaning it is built for repeated use across multiple cardiac emergencies. This design allows for deployment in pre-hospital, hospital, and public-access settings where reliability and durability are critical.

• What types of environments is the Zoll X Series compatible with, and are there any specific limitations?

  The Zoll X Series is designed to operate in MRI environments, but its use must follow the manufacturer’s technical documentation for safety and compatibility. It is also intended for pre-hospital, hospital, and public-access settings, where its defibrillation, cardioversion, and pacing capabilities are utilized.

• How does the Zoll X Series guide users through resuscitation, and what advanced features does it include?

  The Zoll X Series incorporates advanced algorithms that analyze heart rhythms in real time, providing step-by-step guidance to rescue personnel during resuscitation. It combines defibrillation, cardioversion, and pacing capabilities to help restore normal heart rhythm in patients experiencing sudden cardiac arrest.

• What regulatory pathway was followed for the Zoll X Series, and which advisory committee was involved?

  The Zoll X Series was cleared through the FDA 510(k) pathway under the classification of Class III devices (870.5310). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the device was determined to be substantially equivalent to predicate technologies. The clearance number is K112432.

• What settings or environments is the Zoll X Series intended for, and how does its design support those uses?

  The Zoll X Series is designed for pre-hospital, hospital, and public-access settings, where its reusable and durable construction ensures reliability in emergency scenarios. Its advanced algorithms and multi-functionality (defibrillation, cardioversion, and pacing) make it suitable for diverse environments where sudden cardiac arrest may occur.