Cleared Special

K122130 - WINX SLEEP THERAPY SYSTEM

K122130 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 Special 510(k) pathway after a 105-day FDA review.

K122130 · Apnicure, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
105d
Days
Class 2
Risk

K122130 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 October 31, 2012 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122130

510(k) Number K122130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2012
Decision Date October 31, 2012
Days to Decision 105 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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.

K122130 · WINX SLEEP THERAPY SYSTEM
Download PDF FDA Summary Apnicure, Inc.