Propaq MD

• • 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

Full name

Zoll Propaq Md

510(k) Number

K112761 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• 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 Propaq MD intended for use in, and why is this important for my application?

  The ZOLL Propaq MD is specifically designed for pre-hospital and transport settings, including military and air medical operations. This distinction is important because it ensures the device meets the rigorous demands of mobile, high-stress environments where immediate cardiac intervention is critical. Its portability and advanced features—such as defibrillation, non-invasive pacing, and continuous monitoring—are optimized for scenarios where traditional hospital-based equipment may not be accessible.

• Is the ZOLL Propaq MD a single-use device, or can it be reused? What does this mean for maintenance and cost?

  The ZOLL Propaq MD is not single-use—it is classified as a reusable medical device. This means it requires regular maintenance, calibration, and cleaning according to the manufacturer’s instructions to ensure reliability and safety. While this avoids the cost of disposable units, it introduces ongoing operational expenses for servicing and training staff to handle the device properly.

• What training or certification is required to operate the ZOLL Propaq MD effectively?

  The device requires proper training for operation, as stated in the manufacturer’s guidelines. This is critical because it combines advanced therapeutic functions (shock delivery and pacing) with continuous monitoring, demanding proficiency to avoid misapplication or delays in emergency care. Training ensures operators can interpret readings and respond appropriately in critical situations.

• How is the ZOLL Propaq MD’s regulatory status relevant to my procurement or clinical use?

  The device holds FDA 510(k) clearance under Class III, meaning it has undergone rigorous review by the U.S. Food and Drug Administration to demonstrate safety and effectiveness for its intended use. This classification is important because it signals compliance with stringent regulatory standards, though it does not imply approval for specific clinical indications—only that the device meets FDA requirements for its designated purpose in pre-hospital and transport settings.