Cleared Traditional

K130684 - PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR

K130684 is an FDA 510(k) clearance for PHILIPS HEARTSTART FR3 AUTOMATED EXTERN..., manufactured by Philips Medical Systems. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K130684 · Philips Medical Systems · Cardiovascular device
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Oct 2013
Decision
219d
Days
Class 3
Risk

K130684 is an FDA 510(k) clearance for the PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on October 18, 2013 after a review of 219 days - an extended review cycle.

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.

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FDA 510(k) Submission Details - K130684

510(k) Number K130684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date October 18, 2013
Days to Decision 219 days
Submission Type Traditional
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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 142
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