Cleared Traditional

K132003 - WINX SLEEP THERAPY SYSTEM

K132003 is an FDA 510(k) clearance for WINX SLEEP THERAPY SYSTEM, manufactured by Apnicure, Inc.. The device is a Class 2 Anesthesiology device with product code OZR cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K132003 · Apnicure, Inc. · Anesthesiology device
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Jun 2014
Decision
347d
Days
Class 2
Risk

K132003 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 June 13, 2014 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 872.5570 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Apnicure, Inc. devices

FDA 510(k) Submission Details - K132003

510(k) Number K132003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date June 13, 2014
Days to Decision 347 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 140d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OZR Device Classification - Class 2, Special Controls

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.