Cleared Abbreviated

K061707 - HEARTSTART MRX

K061707 is the FDA 510(k) clearance for HEARTSTART MRX by Philips Medical Systems. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K061707 · Philips Medical Systems · Cardiovascular device
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Aug 2006
Decision
56d
Days
Class 3
Risk

K061707 is an FDA 510(k) clearance for the HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS. 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 August 11, 2006 after a review of 56 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

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

Submission Details

510(k) Number K061707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2006
Decision Date August 11, 2006
Days to Decision 56 days
Submission Type Abbreviated
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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 47
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K061707.
PHILIPS HEARTSTART SMARTPADS III
K072812 · Philips Medical Systems · Feb 2008
HEARTSTART MRX, MODELS M3535A OR M3536A
K063375 · Philips Medical Systems · Jan 2007
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233 · Philips Medical Systems North America, Inc. · Nov 2006
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
K051632 · Philips Medical Systems · Oct 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134 · Philips Medical Systems · Sep 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004 · Philips Medical Systems · Feb 2005