Not Cleared Post-NSE

DEN070014 - MANDOMETER III (FDA 510(k) Clearance)

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

DEN070014 · Ab Mando · Neurology device
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Mar 2011
Decision
1380d
Days
Class 2
Risk

DEN070014 is an FDA 510(k) submission (not cleared) for the MANDOMETER III. Classified as Eating Disorder Conditioning Tool (product code OBV), Class II - Special Controls.

Submitted by Ab Mando (San Diego, US). The FDA issued a Not Cleared (DENG) decision on March 31, 2011 after a review of 1380 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5060 - the FDA neurology 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 1380 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 DEN070014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 20, 2007
Decision Date March 31, 2011
Days to Decision 1380 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1232d slower than avg
Panel avg: 148d · This submission: 1380d
Pathway characteristics

Device Classification

Product Code OBV Eating Disorder Conditioning Tool
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5060
Definition A Conditioning Tool For Eating Disorders Is A Medical Device That Non-invasively Measures The Mass Of Food Eaten During A Meal And Provides Feedback In The Form Of Eating Rate, Patient Satiety, And Eating Pattern Information To The Patient.
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 Neurology devices follow this clearance model.