Cleared Special

K050004 - PHILIPS HEARTSTART FRX DEFIBRILLATOR

K050004 is the FDA 510(k) clearance for PHILIPS HEARTSTART FRX DEFIBRILLATOR by Philips Medical Systems. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Special 510(k) pathway after a 54-day FDA review.

K050004 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
54d
Days
Class 3
Risk

K050004 is an FDA 510(k) clearance for the PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Philips Medical Systems (Seattle, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 54 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

Submission Details

510(k) Number K050004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2005
Decision Date February 25, 2005
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 K050004.
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
K061707 · Philips Medical Systems · Aug 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
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · Welch Allyn, Inc. · Sep 2004
HEARTSTART MRX, MODEL M3535A
K040404 · Philips Medical Systems, Inc. · May 2004
HEARTSTART MRX, MODEL M3535A
K031187 · Philips Medical Systems · Aug 2003