Cleared Traditional

K020984 - ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

K020984 is an FDA 510(k) clearance for ACCESSAED, manufactured by Access Cardiosystems, 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.

K020984 · Access Cardiosystems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
149d
Days
Class 3
Risk

K020984 is an FDA 510(k) clearance for the ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Access Cardiosystems, Inc. (Concord, US). The FDA issued a Cleared decision on August 14, 2002 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 - K020984

510(k) Number K020984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 18, 2002
Decision Date August 14, 2002
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
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 227
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K020984.
INFANT/CHILD REDUCED ENERGY ELECTRODES
K022732 · Medtronic Physio-Control Corp. · Dec 2002
PHILIPS M5066A AND M5068A
K020715 · Philips Medical Systems · Nov 2002
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
K022210 · Cardiac Science, Inc. · Oct 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · Philips Medical Systems · Jul 2002
JUMP START, MODEL 970300
K021168 · Medical Research Laboratories, Inc. · Jun 2002
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
K013896 · Defibtech, LLC · Jun 2002
K020984 · ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
Download PDF Access Cardiosystems,…