Not Cleared Direct

DEN130046 - REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE (FDA 510(k) Clearance)

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

DEN130046 · Somna Therapeutics, LLC · Ear, Nose, Throat device
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Mar 2015
Decision
477d
Days
Class 2
Risk

DEN130046 is an FDA 510(k) submission (not cleared) for the REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE. Classified as External Upper Esophageal Sphincter (ues) Compression Device (product code PKA), Class II - Special Controls.

Submitted by Somna Therapeutics, LLC (Germantown, US). The FDA issued a Not Cleared (DENG) decision on March 6, 2015 after a review of 477 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5900 - 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. High predicate equivalence gap. With 477 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 Somna Therapeutics, LLC devices

Submission Details

510(k) Number DEN130046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 14, 2013
Decision Date March 06, 2015
Days to Decision 477 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
388d slower than avg
Panel avg: 89d · This submission: 477d
Pathway characteristics

Device Classification

Product Code PKA External Upper Esophageal Sphincter (ues) Compression Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.5900
Definition The External Ues Compression Device Is Intended To Reduce The Symptoms Of Laryngopharyngeal Reflux (lpr) Disease By Reducing The Regurgitation Of Stomach Contents From Passing Through The Upper Esophageal Sphincter.
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.