510(k) Report

FDA product code · Anesthesiology

Intraoral Pressure Gradient Device

OZRClass II21 CFR 872.5570510(k) required6 decisions since 20120 recalls

6 FDA decisions since 2012. 510(k) reviews decided 2021–2025 took a median of 444 days (half between 444 and 444). No recall names this code. The most-cited predicate is K111549, named by 3 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, anesthesiology panel

Twenty years of OZR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OZR

1in 2023

2012: 22013: 12014: 12020: 12023: 1
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OZR

Too few OZR 510(k)s in any year since 2007 to give a median.

Recalls per year · OZR

No recall names OZR since 2007.

Adverse event reports per year · OZR

1in 2017

2014: 12017: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code OZR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20122—00
20131—00
20141—01
20150—00
20160—00
20170—01
20180—00
20190—00
20201—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — OZR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OZR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OZR devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K111549Attune Sleep Apnea SystemApnicure, Inc. · 20123cite it
  • K193460The iNAP One Sleep Therapy SystemSomnice, Inc. · 20201cites it
  • K130538Winx Sleep Therapy SystemApnicure, Inc. · 20131cites it
  • K122130Winx Sleep Therapy SystemApnicure, Inc. · 20121cites it

Which OZR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K220907The iNAP One Sleep Therapy SystemSomnics, Inc. · 202313generations
  • K193460The iNAP One Sleep Therapy SystemSomnice, Inc. · 202012generations
  • K130538Winx Sleep Therapy SystemApnicure, Inc. · 201311generations
  • K132003Winx Sleep Therapy SystemApnicure, Inc. · 201410generations
  • K122130Winx Sleep Therapy SystemApnicure, Inc. · 201210generations
  • K111549Attune Sleep Apnea SystemApnicure, Inc. · 20129generations

What has FDA decided in OZR lately?

  • K220907The iNAP One Sleep Therapy SystemSomnics, Inc. · 2023
  • K193460The iNAP One Sleep Therapy SystemSomnice, Inc. · 2020
  • K132003Winx Sleep Therapy SystemApnicure, Inc. · 2014
  • K130538Winx Sleep Therapy SystemApnicure, Inc. · 2013
  • K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012
  • K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012

All 6 OZR decisions →

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