Not Cleared Post-NSE

DEN100013 - VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 (FDA 510(k) Clearance)

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

DEN100013 · Vioguard · General Hospital
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Dec 2011
Decision
410d
Days
Class 2
Risk

DEN100013 is an FDA 510(k) submission (not cleared) for the VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50. Classified as Antimicrobial Keyboard (product code OSZ), Class II - Special Controls.

Submitted by Vioguard (Bothell, US). The FDA issued a Not Cleared (DENG) decision on December 20, 2011 after a review of 410 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6600 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 410 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.

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Submission Details

510(k) Number DEN100013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 05, 2010
Decision Date December 20, 2011
Days to Decision 410 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
282d slower than avg
Panel avg: 128d · This submission: 410d
Pathway characteristics

Device Classification

Product Code OSZ Antimicrobial Keyboard
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6600
Definition To Reduce Microbial Populations
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.