Therapeutic devices · 21 CFR 872 Subpart F
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.
- Companies listing it
- 22 makers
- Brands and models
- 3
- 510(k) clearances
- 61 in five years
- FDA name
- Intraoral Pressure Gradient Device
510(k) clearances per year, 1976–2026
Companies that list OZR
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Somnics, Inc. | Taiwan | Maker | iNAP One Sleep Therapy System · The iNAP One Sleep Therapy System | 2 | 2023 |
| Medeologix LLC | United States | Maker | iNAP One Sleep Therapy System | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Jun 2023 | K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. |
| 26 May 2020 | K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. |
| 13 Jun 2014 | K132003 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. |
| 22 May 2013 | K130538 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. |
| 31 Oct 2012 | K122130 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. |
| 30 Mar 2012 | K111549 | ATTUNE SLEEP APNEA SYSTEM | Apnicure, Inc. |
Official records: FDA product classification for OZR · 21 CFR 872.5570.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026