Cleared Special

K020203 - PADPRO MODEL #2516

K020203 is an FDA 510(k) clearance for PADPRO MODEL #2516, manufactured by Padpro, LLC. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 106-day FDA review.

K020203 · Padpro, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
106d
Days
Class 3
Risk

K020203 is an FDA 510(k) clearance for the PADPRO MODEL #2516. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Padpro, LLC (Deer Field, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K020203

510(k) Number K020203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date May 08, 2002
Days to Decision 106 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 227
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K020203.
JUMP START, MODEL 970300
K021168 · Medical Research Laboratories, Inc. · Jun 2002
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
K013896 · Defibtech, LLC · Jun 2002
PADPRO, MODEL 2502
K020743 · Padpro, LLC · May 2002
ZOLL PAD WITH CPR AID
K011541 · Zoll Medical Corp · Apr 2002
ZOLL PAD
K011388 · Zoll Medical Corp · Mar 2002
PADPRO, MODEL 2603
K020288 · Padpro, LLC · Feb 2002
K020203 · PADPRO MODEL #2516
Download PDF FDA Summary Padpro, LLC