Not Cleared Direct

DEN250005 - Sana Device (FDA 510(k) Clearance)

Class I Neurology device.

DEN250005 · Sana Health · Neurology device
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Jan 2026
Decision
319d
Days
Class 1
Risk

DEN250005 is an FDA 510(k) submission (not cleared) for the Sana Device. Classified as Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use) (product code QYN), Class I - General Controls.

Submitted by Sana Health (Louisville, US). The FDA issued a Not Cleared (DENG) decision on January 16, 2026 after a review of 319 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5775 - 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 319 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 DEN250005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 03, 2025
Decision Date January 16, 2026
Days to Decision 319 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 148d · This submission: 319d
Pathway characteristics

Device Classification

Product Code QYN Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5775
Definition An Avs Is A Prescription Use Device Intended For Temporary Pain Relief And Is Used Adjunctively With Other Pain Therapies
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.