OZR · Class II · 21 CFR 872.5570

FDA Product Code OZR: Intraoral Pressure Gradient Device

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.

Leading manufacturers include Apnicure, Inc., Somnice, Inc. and Somnics, Inc..

6
Total
6
Cleared
240d
Avg days
2012
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Intraoral Pressure Gradient Device Devices (Product Code OZR)

6 devices
1–6 of 6
Cleared Jun 16, 2023
The iNAP One Sleep Therapy System
K220907
Somnics, Inc.
Anesthesiology · 444d
Cleared May 26, 2020
The iNAP One Sleep Therapy System
K193460
Somnice, Inc.
Anesthesiology · 162d
Cleared Jun 13, 2014
WINX SLEEP THERAPY SYSTEM
K132003
Apnicure, Inc.
Anesthesiology · 347d
Cleared May 22, 2013
WINX SLEEP THERAPY SYSTEM
K130538
Apnicure, Inc.
Anesthesiology · 82d
Cleared Oct 31, 2012
WINX SLEEP THERAPY SYSTEM
K122130
Apnicure, Inc.
Anesthesiology · 105d
Cleared Mar 30, 2012
ATTUNE SLEEP APNEA SYSTEM
K111549
Apnicure, Inc.
Anesthesiology · 301d

About Product Code OZR - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code OZR since 2012, with 6 receiving FDA clearance (average review time: 240 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.