Not Cleared Direct

DEN230045 - Sonu (FDA 510(k) Clearance)

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

DEN230045 · Sound Health Systems, Inc. · Ear, Nose, Throat device
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Dec 2023
Decision
171d
Days
Class 2
Risk

DEN230045 is an FDA 510(k) submission (not cleared) for the Sonu. Classified as External Mechanical Stimulator For The Relief Of Congestion (product code QZC), Class II - Special Controls.

Submitted by Sound Health Systems, Inc. (Los Altos, US). The FDA issued a Not Cleared (DENG) decision on December 4, 2023 after a review of 171 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.6010 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Ear, Nose, Throat review framework.

View all Sound Health Systems, Inc. devices

Submission Details

510(k) Number DEN230045 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 16, 2023
Decision Date December 04, 2023
Days to Decision 171 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
82d slower than avg
Panel avg: 89d · This submission: 171d
Pathway characteristics

Device Classification

Product Code QZC External Mechanical Stimulator For The Relief Of Congestion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.6010
Definition The External Mechanical Stimulator For The Relief Of Congestion Delivers Vibrations To The Sinus And Nasal Areas To Relieve Congestion.
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.