Not Cleared Post-NSE

DEN060009 - 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE (FDA 510(k) Clearance)

Also includes:
3M N95 HOME RESPIRATOR

Class II General Hospital device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060009 · 3M Company · General Hospital
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May 2007
Decision
217d
Days
Class 2
Risk

DEN060009 is an FDA 510(k) submission (not cleared) for the 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE. Classified as Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (product code NZJ), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Not Cleared (DENG) decision on May 8, 2007 after a review of 217 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6260 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General Hospital review framework.

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Submission Details

510(k) Number DEN060009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 03, 2006
Decision Date May 08, 2007
Days to Decision 217 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 128d · This submission: 217d
Pathway characteristics

Device Classification

Product Code NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6260
Definition It Is Intended To Cover The Nose And Mouth Of The Wearer To Help Reduce Wearer Exposure To Pathogenic Biological Airborne Particulates During Public Health Medical Emergencies, Such As Influenza Pandemic And Also Protects The Wearer From Splash And Spray Of Body Fluids.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.