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

by Padpro, LLC

510(k) K014209

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK014209 Date18 Jan 2002ClearedStatusActive

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0454-2015 FDA Class I initiated 6 Nov 2014
    • Terminated Z-0455-2015 FDA Class I initiated 6 Nov 2014
    • Terminated Z-0456-2015 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.

    • Terminated Z-1317-2013 FDA Class II initiated 3 May 2013

    ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MKJ
Models / Variants
2001-S
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Padpro Model 2001, 2001-S, 2001-C, and 2001-EPS are Automated External Defibrillators (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. These devices are portable, non-invasive, and intended for use by trained responders in both pre-hospital and in-hospital settings to treat ventricular fibrillation and pulseless ventricular tachycardia.

These defibrillators are supplied as single-use or reusable systems, depending on the model variant, and are classified as Class III medical devices under FDA regulations. They require proper training for operation and are intended for emergency use only. The devices are authorized under FDA 510K clearance (K014209) and adhere to regulatory standards outlined in 21 CFR 870.5310. Storage and handling follow manufacturer guidelines to ensure functionality and safety.

Other devices from Padpro, LLC

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these defibrillators designed for single-use or reusable applications, and how does that affect their maintenance requirements?

    The Padpro Model 2001 series includes both single-use and reusable variants. The 2001 and 2001-S models are designed for single-use, meaning they are intended for one-time deployment and disposal after use. In contrast, the 2001-C and 2001-EPS models are reusable, requiring regular maintenance, calibration, and cleaning as specified by the manufacturer to ensure proper functionality and safety. Reusable models must adhere to strict protocols to prevent cross-contamination and maintain performance over multiple uses.

  • What types of cardiac emergencies are these defibrillators specifically intended to treat, and why is training required?

    These devices are specifically designed to treat ventricular fibrillation and pulseless ventricular tachycardia, two life-threatening cardiac rhythms that disrupt normal heart function and require immediate intervention. Training is required because operating an automated external defibrillator (AED) involves assessing the patient’s condition, applying pads correctly, delivering shocks at the right energy level, and performing CPR—all of which demand proficiency to ensure effective resuscitation. Proper training minimizes risks like misapplication or delayed intervention.

  • How should these defibrillators be stored to ensure they remain functional and safe for emergency use?

    The manufacturer provides specific storage guidelines to maintain functionality and safety. These devices should be stored in a clean, dry environment away from extreme temperatures, direct sunlight, and sources of electromagnetic interference. Reusable models (e.g., 2001-C and 2001-EPS) require periodic maintenance checks, while single-use models (e.g., 2001 and 2001-S) should be stored in their original packaging until deployment. Adhering to these guidelines ensures the device remains operational when needed for emergency cardiac arrest scenarios.

  • What distinguishes the 2001-EPS model from the other variants, and is it suitable for both pre-hospital and in-hospital use?

    The 2001-EPS model is a reusable variant of the Padpro series, likely incorporating extended power supply (EPS) capabilities, which may include longer battery life or enhanced features for sustained use in prolonged emergencies. Like all models, it is designed for both pre-hospital and in-hospital settings to treat ventricular fibrillation and pulseless ventricular tachycardia. Its reusability makes it particularly useful in environments where multiple rescues may occur, such as hospitals or high-traffic emergency response areas.