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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 140d · This submission: 347d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01634074 Unknown Observational Industry-sponsored

Reiterative Development and Evaluation Study of OSA Therapy System

A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

150
Patients (est.)
7
Sites
Condition studied Obstructive Sleep Apnea
Eligibility All sexes · 18 Years+
Principal investigator Mehran Farid-Moayer, MD
Sponsor ApniCure, Inc. (industry)
Started 2012-07-01 → Primary completion 2014-07-01
View full study on ClinicalTrials.gov

Regulatory Peers - OZR Intraoral Pressure Gradient Device

Devices cleared under the same product code (OZR) and FDA review panel - the closest regulatory comparables to K132003.
The iNAP One Sleep Therapy System
K220907 · Somnics, Inc. · Jun 2023
The iNAP One Sleep Therapy System
K193460 · Somnice, Inc. · May 2020
WINX SLEEP THERAPY SYSTEM
K130538 · Apnicure, Inc. · May 2013
WINX SLEEP THERAPY SYSTEM
K122130 · Apnicure, Inc. · Oct 2012
ATTUNE SLEEP APNEA SYSTEM
K111549 · Apnicure, Inc. · Mar 2012
K132003 · WINX SLEEP THERAPY SYSTEM
Download PDF FDA Summary Apnicure, Inc.