FDA product code OZR: Intraoral Pressure Gradient Device
OZR is the FDA product code for intraoral pressure gradient device. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under OZR, 1 in the last five years, from 3 different applicants. The average 510(k) review took 240 days (median 232).
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.
Classification
| Field | Value |
|---|---|
| Device name | Intraoral Pressure Gradient Device |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OZR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 162 |
| 2023 | 1 | 444 |
Compare with all 510(k) review times · Search every OZR clearance
Top OZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apnicure, Inc. | 4 | 2014-06-13 |
| Somnics, Inc. | 1 | 2023-06-16 |
| Somnice, Inc. | 1 | 2020-05-26 |
Most recent OZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220907 | Somnics, Inc. | The iNAP One Sleep Therapy System | 2023-06-16 | 444 |
| K193460 | Somnice, Inc. | The iNAP One Sleep Therapy System | 2020-05-26 | 162 |
| K132003 | Apnicure, Inc. | WINX SLEEP THERAPY SYSTEM | 2014-06-13 | 347 |
| K130538 | Apnicure, Inc. | WINX SLEEP THERAPY SYSTEM | 2013-05-22 | 82 |
| K122130 | Apnicure, Inc. | WINX SLEEP THERAPY SYSTEM | 2012-10-31 | 105 |
Recalls for OZR devices
openFDA lists no recalls for product code OZR.
Frequently asked questions
What is FDA product code OZR?
OZR is the FDA product code for intraoral pressure gradient device. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Anesthesiology panel.
What device class is OZR?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZR?
Across 6 cleared submissions the average was 240 days from receipt to decision (median 232).
Which companies have the most OZR clearances?
Apnicure, Inc. (4); Somnics, Inc. (1); Somnice, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OZR
- Run a recall and safety report across every OZR manufacturer
- Watch product code OZR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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