Not Cleared Direct

DEN150033 - Sensor Monitored Alimentary Restriction Therapy (SMART) Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150033 · Scientific Intake · Gastroenterology & Urology device
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Sep 2016
Decision
423d
Days
Class 2
Risk

DEN150033 is an FDA 510(k) submission (not cleared) for the Sensor Monitored Alimentary Restriction Therapy (SMART) Device. Classified as Oral Removable Retainer For Weight Management (product code ONY), Class II - Special Controls.

Submitted by Scientific Intake (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on September 26, 2016 after a review of 423 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5981 - the FDA gastroenterology and urology 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 423 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 DEN150033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 31, 2015
Decision Date September 26, 2016
Days to Decision 423 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 130d · This submission: 423d
Pathway characteristics

Device Classification

Product Code ONY Oral Removable Retainer For Weight Management
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5981
Definition A Removable Oral Device Used During Meals To Limit Food Intake.
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 Gastroenterology & Urology devices follow this clearance model.