OZR
6 FDA 510(k) clearances · Product code
301 daysmedian time to decision
444 days90th percentile
6clearances measured
FDA profile
- Official device name
- Intraoral Pressure Gradient Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| The iNAP One Sleep Therapy System (K220907) | Somnics, Inc. | 2023-06-16 |
| The iNAP One Sleep Therapy System (K193460) | Somnice, Inc. | 2020-05-26 |
| WINX SLEEP THERAPY SYSTEM (K132003) | Apnicure, Inc. | 2014-06-13 |
| WINX SLEEP THERAPY SYSTEM (K130538) | Apnicure, Inc. | 2013-05-22 |
| WINX SLEEP THERAPY SYSTEM (K122130) | Apnicure, Inc. | 2012-10-31 |
| ATTUNE SLEEP APNEA SYSTEM (K111549) | Apnicure, Inc. | 2012-03-30 |
Track OZR automatically
Every clearance here is in the API, with alerts when new ones post.