Cleared Special

K130538 - WINX SLEEP THERAPY SYSTEM (FDA 510(k) Clearance)

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

K130538 · Apnicure, Inc. · Anesthesiology device
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May 2013
Decision
82d
Days
Class 2
Risk

K130538 is an FDA 510(k) clearance for the WINX SLEEP THERAPY SYSTEM. Classified as Intraoral Pressure Gradient Device (product code OZR), Class II - Special Controls.

Submitted by Apnicure, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 22, 2013 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 872.5570 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apnicure, Inc. devices

Submission Details

510(k) Number K130538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date May 22, 2013
Days to Decision 82 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 139d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OZR Intraoral Pressure Gradient Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition This Intraoral Device Is Electrically Powered And Operates By Reducing The Pressure In The Oral Cavity (by Way Of Tubing And A Noninvasive Oral Interface) To Create A Continuous Positive Pressure Gradient From The Airway To The Oral Cavity That Urges The Soft Palate And Tongue Forward. It Is Intended To Be Used While A Patient Is Sleeping To Treat Obstructive Sleep Apnea.
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.