Padpro Model 2502

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

510(k) Number

K020743 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• PadPro Model 2516

  Class III

  FDA 510(k) K020203 Active Cleared 8 May 2002

• What is the primary use case for the Padpro Model 2502, and who should operate it?

  The Padpro Model 2502 is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest outside of a hospital setting. It is intended for use by trained personnel in emergency situations, such as first responders, EMS providers, or trained bystanders in public or workplace environments where cardiac arrest may occur.

• Is the Padpro Model 2502 a single-use or reusable device, and how should it be maintained?

  The Padpro Model 2502 is a reusable device, meaning it is built to be used multiple times with proper care. To ensure functionality and safety, it must be stored and maintained according to the manufacturer’s guidelines, which likely include regular inspections, cleaning, and calibration as specified by Padpro, LLC.

• Can this device be used in an MRI environment, and what regulatory pathway does it follow?

  The Padpro Model 2502 is not MRI-safe, meaning it should not be used in or near an MRI scanner. Regulatory-wise, it follows the FDA 510(k) clearance pathway (K020743) as a Class III medical device under regulation number 870.5310, indicating it has been deemed substantially equivalent to a predicate device for cardiovascular emergency response.

• What training is required to operate the Padpro Model 2502 effectively?

  The Padpro Model 2502 requires proper training for operation, as stated in the manufacturer’s instructions. This likely includes hands-on practice with the device, understanding how to apply pads correctly, interpreting voice prompts, and administering shocks safely. Training should align with guidelines from organizations like the American Heart Association (AHA) or local emergency medical services (EMS) protocols.