Cleared Special

K993533 - POWERHEART AECD

K993533 is an FDA 510(k) clearance for POWERHEART AECD, manufactured by Cardiac Science, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 97-day FDA review.

K993533 · Cardiac Science, Inc. · Cardiovascular device
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Jan 2000
Decision
97d
Days
Class 3
Risk

K993533 is an FDA 510(k) clearance for the POWERHEART AECD. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Cardiac Science, Inc. (Irvine, US). The FDA issued a Cleared decision on January 24, 2000 after a review of 97 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.

View all Cardiac Science, Inc. devices

FDA 510(k) Submission Details - K993533

510(k) Number K993533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 19, 1999
Decision Date January 24, 2000
Days to Decision 97 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 143
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K993533.
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
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ZOLL M SERIES ETCO2 OPTION
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K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
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HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · Hewlett-Packard Co. · Dec 1999
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K991556 · Zoll Medical Corp · Oct 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762 · Zoll Medical Corp · Sep 1999