PadPro Model 2516

• 2 recalls, same reason

  • Terminated Z-0458-2015 FDA Class I ·initiated 6 Nov 2014
  • Terminated Z-0457-2015 FDA Class I ·initiated 6 Nov 2014

  Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

• 2 recalls, same reason

  • Terminated Z-0756-2007 FDA Unclassified (pre-2012) ·initiated 8 Mar 2007 ·on shared 510(k) K020203
  • Terminated Z-0757-2007 FDA Unclassified (pre-2012) ·initiated 8 Mar 2007 ·on shared 510(k) K020203

  Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K020203 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Padpro Model 2502

  Class III

  FDA 510(k) K020743 Active Cleared 28 May 2002

• PadPro Model 2603

  Class III

  FDA 510(k) K020288 Active Cleared 27 Feb 2002

• Padpro System Defibrillator Electrode Adapters

  Class III

  FDA 510(k) K003548 Active Cleared 4 Sep 2001

• Padpro Model 2001, 2001-S, 2001-C, 2001-EPS

  Class III

  FDA 510(k) K014209 Active Cleared 18 Jan 2002

• Can the PadPro Model 2516 be reused after a single use, or is it strictly single-use only?

  The PadPro Model 2516 is designed as a single-use or reusable system, as indicated in the regulatory submission. Whether it is reused depends on facility protocols and maintenance practices, but the device itself is not inherently restricted to single-use. Reuse must follow proper cleaning, disinfection, and inspection procedures to ensure safety and functionality, especially since it is classified as a Class III medical device under FDA regulations.

• What types of environments or settings is the PadPro Model 2516 intended for, and how does its design support those uses?

  The PadPro Model 2516 is specifically designed for pre-hospital and public access defibrillation programs, meaning it is meant for emergency responders and lay rescuers outside of clinical settings (e.g., ambulances, public spaces, or worksites). Its design includes external electrodes for defibrillation, pacing, and cardiac monitoring, allowing non-medical personnel to manage sudden cardiac events effectively. The device does not have MRI safety restrictions, making it suitable for general emergency use.

• How should the PadPro Model 2516 be stored, and are there any special handling requirements for this device?

  Storage and handling of the PadPro Model 2516 follow standard protocols for defibrillator equipment, as noted in the regulatory data. Since it is non-sterile, it does not require sterile storage conditions, but it should be kept in a clean, dry environment to prevent damage or contamination. If reused, it must undergo proper cleaning and maintenance to ensure reliability. Always refer to the manufacturer’s instructions for specific storage guidelines.

• What regulatory pathway was followed for the FDA clearance of the PadPro Model 2516, and what does that mean for its use?

  The PadPro Model 2516 was cleared via an FDA 510(k) pathway (K020203), classified as Substantially Equivalent (SESE) under the Cardiovascular (CV) Advisory Committee. This means the device was determined to be at least as safe and effective as a legally marketed predicate device, allowing it to enter the market without requiring a full Premarket Approval (PMA). The clearance adheres to 21 CFR 870.5310, ensuring compliance with FDA standards for Automated External Defibrillators (Non-Wearable).