Cleared Abbreviated

K020715 - PHILIPS M5066A AND M5068A

K020715 is an FDA 510(k) clearance for PHILIPS M5066A AND M5068A, manufactured by Philips Medical Systems. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Abbreviated 510(k) pathway after a 248-day FDA review.

K020715 · Philips Medical Systems · Cardiovascular device
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Nov 2002
Decision
248d
Days
Class 3
Risk

K020715 is an FDA 510(k) clearance for the PHILIPS M5066A AND M5068A. 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 November 8, 2002 after a review of 248 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 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.

FDA 510(k) Submission Details - K020715

510(k) Number K020715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 05, 2002
Decision Date November 08, 2002
Days to Decision 248 days
Submission Type Abbreviated
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
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Standards-based clearance path.

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
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K020715 · PHILIPS M5066A AND M5068A
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