Not Cleared Post-NSE

DEN050007 - HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN050007 · Fmg Innovations, Inc. · Ear, Nose, Throat device
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Mar 2006
Decision
280d
Days
Class 2
Risk

DEN050007 is an FDA 510(k) submission (not cleared) for the HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL. Classified as Kit, Test, Olfactory (product code NRK), Class II - Special Controls.

Submitted by Fmg Innovations, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on March 27, 2006 after a review of 280 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1600 - the FDA ear, nose and throat 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. Elevated predicate reliance profile. With 280 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 Fmg Innovations, Inc. devices

Submission Details

510(k) Number DEN050007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 20, 2005
Decision Date March 27, 2006
Days to Decision 280 days
Submission Type Post-NSE
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 89d · This submission: 280d
Pathway characteristics

Device Classification

Product Code NRK Kit, Test, Olfactory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1600
Definition The Home Test For Loss Of The Sense Of Smell Is Packaged In A Small Carton Which Contains (1) An Instruction Book, (2) A Booklet Containing Twelve Micorencapsulated Smell Strips, Each On A Separate Page, With Instructions For Scoring The Test And An Answer Key, And (3) A Physician Information Card. The Device Is Intended For Screening Neurological Disorder.
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 Ear, Nose, Throat devices follow this clearance model.