Not Cleared Direct

DEN230041 - Sleep Apnea Feature (FDA 510(k) Clearance)

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

DEN230041 · Samsung Electronics Co., Ltd. · Anesthesiology device
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Feb 2024
Decision
251d
Days
Class 2
Risk

DEN230041 is an FDA 510(k) submission (not cleared) for the Sleep Apnea Feature. Classified as Over-the-counter Device To Assess Risk Of Sleep Apnea (product code QZW), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Not Cleared (DENG) decision on February 6, 2024 after a review of 251 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2378 - 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 251 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 DEN230041 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 31, 2023
Decision Date February 06, 2024
Days to Decision 251 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 139d · This submission: 251d
Pathway characteristics

Device Classification

Product Code QZW Over-the-counter Device To Assess Risk Of Sleep Apnea
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2378
Definition An Over-the-counter Device To Assess Risk Of Sleep Apnea Is Intended To Provide A Notification Of The Risk Of Sleep Apnea In Users Who Have Not Been Previously Diagnosed With Sleep Apnea. This Device Uses Software Algorithms To Analyze Input Sensor Signals And Provide A Risk Assessment For Sleep Apnea. It Is Not Intended To Provide A Standalone Diagnosis, Replace Traditional Methods Of Diagnosis (e.g., Polysomnography), Assist Clinicians In Diagnosing Sleep Disorders, Or 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.