Zoll AEDPro with See-Thru CPR, Model AEDPro

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

510(k) Number

K071025 ↗

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 AEDPro with See-Thru CPR intended for use in, and who can operate it?

  The Zoll AEDPro with See-Thru CPR is designed for use in pre-hospital, emergency, and clinical settings. It is intended for trained responders, including first responders, emergency medical technicians (EMTs), and healthcare professionals who have undergone proper training for operation and maintenance.

• Is the Zoll AEDPro with See-Thru CPR a single-use or reusable device, and how should it be maintained?

  The Zoll AEDPro with See-Thru CPR is a reusable medical device. Like all reusable devices, it requires regular maintenance, cleaning, and calibration as per the manufacturer’s guidelines to ensure proper functionality and safety. Training for operation and maintenance is mandatory.

• What kind of regulatory clearance does the Zoll AEDPro with See-Thru CPR have, and how was it determined?

  The Zoll AEDPro with See-Thru CPR has received FDA 510(k) clearance through a Special Review process by the Cardiovascular Advisory Committee. The device was determined to be substantially equivalent to a legally marketed predicate device, meeting FDA requirements for Class III medical devices.

• Does the Zoll AEDPro with See-Thru CPR provide any additional features beyond defibrillation, and if so, what are they?

  Yes, the Zoll AEDPro with See-Thru CPR combines defibrillation capabilities with real-time feedback to guide chest compressions during CPR. It provides visual and auditory cues to ensure optimal resuscitation efforts, helping trained responders deliver effective compressions.

• What storage and handling guidelines should be followed for the Zoll AEDPro with See-Thru CPR to ensure its functionality?

  The Zoll AEDPro with See-Thru CPR must be stored and handled according to the manufacturer’s guidelines to maintain its functionality and safety. While specific storage conditions aren’t detailed here, proper care—including protection from physical damage, extreme temperatures, and contamination—is critical for reliable performance.