Cleared Traditional

K040637 - POWERHEART AED G3 PRO

K040637 is an FDA 510(k) clearance for POWERHEART AED G3 PRO, manufactured by Cardiac Science, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K040637 · Cardiac Science, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
149d
Days
Class 3
Risk

K040637 is an FDA 510(k) clearance for the POWERHEART AED G3 PRO. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Cardiac Science, Inc. (Edina, US). The FDA issued a Cleared decision on August 6, 2004 after a review of 149 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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 - K040637

510(k) Number K040637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date August 06, 2004
Days to Decision 149 days
Submission Type Traditional
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
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

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 223
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K040637.
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · Welch Allyn, Inc. · Sep 2004
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
K041883 · Leonhard Lang GmbH · Sep 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
K042088 · Heartsine Technologies, Inc. · Sep 2004
POWERHEART AED G3A
K040438 · Cardiac Science, Inc. · Jul 2004
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K041459 · Medtronic Emergency Response Systems, Inc. · Jul 2004
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
K033896 · Defibtech, LLC · Jun 2004
K040637 · POWERHEART AED G3 PRO
Download PDF FDA Summary Cardiac Science, Inc.