Not Cleared Post-NSE

DEN070002 - QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING (FDA 510(k) Clearance)

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

DEN070002 · Quick-Med Technologies, Inc. · General & Plastic Surgery device
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Feb 2009
Decision
657d
Days
Class 2
Risk

DEN070002 is an FDA 510(k) submission (not cleared) for the QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING. Classified as Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) (product code NYS), Class II - Special Controls.

Submitted by Quick-Med Technologies, Inc. (Gainesville, US). The FDA issued a Not Cleared (DENG) decision on February 25, 2009 after a review of 657 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4015 - the FDA general and plastic surgery 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: Regulatory edge-case submission. High predicate equivalence gap. With 657 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Quick-Med Technologies, Inc. devices

Submission Details

510(k) Number DEN070002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 10, 2007
Decision Date February 25, 2009
Days to Decision 657 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
543d slower than avg
Panel avg: 114d · This submission: 657d
Pathway characteristics

Device Classification

Product Code NYS Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4015
Definition A Wound Dressing With Poly (diallyl Dimethyl Ammonium Chloride) (pdadmac) Additive Is A Device That Is A Sterile Barrier Wound Dressing Intended For Use As A Primary Dressing For Exuding Wounds, First And Second Degree Burns, And Surgical Wounds, To Secure And Prevent Movement Of A Primary Dressing, And As A Wound Packing. The Device Consists Of A Textile Substrate And Permanently Bound Pdadmac. The Device Acts As A Physical Barrier To Outside Contaminants And Does Not Act On The Surface Or Interior Of The Wound Nor Does It Contain Antimicrobial Agents That Act On The Body.
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 & Plastic Surgery devices follow this clearance model.