Cleared Traditional

K173934 - Reza Band, Reflux Band (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173934 · Somna Therapeutics, LLC · Ear, Nose, Throat device
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Apr 2018
Decision
108d
Days
Class 2
Risk

K173934 is an FDA 510(k) clearance for the Reza Band, Reflux Band. 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 Cleared decision on April 13, 2018 after a review of 108 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K173934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date April 13, 2018
Days to Decision 108 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 89d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.