Cleared Special

K063375 - HEARTSTART MRX, MODELS M3535A OR M3536A

K063375 is an FDA 510(k) clearance for HEARTSTART MRX, manufactured by Philips Medical Systems. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 64-day FDA review.

K063375 · Philips Medical Systems · Cardiovascular device
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Jan 2007
Decision
64d
Days
Class 3
Risk

K063375 is an FDA 510(k) clearance for the HEARTSTART MRX, MODELS M3535A OR M3536A. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on January 11, 2007 after a review of 64 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 Philips Medical Systems devices

FDA 510(k) Submission Details - K063375

510(k) Number K063375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date January 11, 2007
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 174
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K063375.
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
K071025 · Zoll Medical Corporation, World Wide Headquarters · Jun 2007
ZOLL E SERIES WITH SEE-THRU CPR
K070455 · Zoll Medical Corporation, World Wide Headquarters · Apr 2007
ZOLL M SERIES WITH REAL CPR HELP
K062537 · ZOLL Medical Corporation · Feb 2007
ZOLL E SERIES WITH REAL CPR HELP
K062177 · ZOLL Medical Corporation · Dec 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
K052465 · Heartsine Technologies, Inc. · Dec 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233 · Philips Medical Systems North America, Inc. · Nov 2006