Cleared Special

K982710 - AECD ARRHYTHMIA DETECTION SOFTWARE

K982710 is an FDA 510(k) clearance for AECD ARRHYTHMIA DETECTION SOFTWARE, 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 6-day FDA review.

K982710 · Cardiac Science, Inc. · Cardiovascular device
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Aug 1998
Decision
6d
Days
Class 3
Risk

K982710 is an FDA 510(k) clearance for the AECD ARRHYTHMIA DETECTION SOFTWARE. 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 August 10, 1998 after a review of 6 days - a notably fast clearance cycle.

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 - K982710

510(k) Number K982710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 04, 1998
Decision Date August 10, 1998
Days to Decision 6 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 125d · This submission: 6d
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 K982710.
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
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