Not Cleared Direct

DEN210015 - Sunrise Sleep Disorder Diagnostic Aid (FDA 510(k) Clearance)

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

DEN210015 · Sunrise · Anesthesiology device
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Jan 2022
Decision
280d
Days
Class 2
Risk

DEN210015 is an FDA 510(k) submission (not cleared) for the Sunrise Sleep Disorder Diagnostic Aid. Classified as Device For Sleep Apnea Testing Based On Mandibular Movement (product code QRS), Class II - Special Controls.

Submitted by Sunrise (Namur, BE). The FDA issued a Not Cleared (DENG) decision on January 7, 2022 after a review of 280 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2376 - the FDA anesthesiology and respiratory 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. Elevated predicate reliance profile. With 280 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 DEN210015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 02, 2021
Decision Date January 07, 2022
Days to Decision 280 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 139d · This submission: 280d
Pathway characteristics

Device Classification

Product Code QRS Device For Sleep Apnea Testing Based On Mandibular Movement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2376
Definition A Device For Sleep Apnea Testing Based On Mandibular Movement Is A Prescription Device Intended To Aid In Evaluation Of Sleep Apnea During Sleep In Patients Suspected Of Having Sleep Breathing Disorders By Analyzing Sensor Readings Of Mandibular Movement. The Device Is Not Intended As A Substitute For Full Polysomnography Nor Intended To Be Used As An Apnea Monitor.
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 Anesthesiology devices follow this clearance model.