OHP
5 FDA 510(k) clearances · Product code
160 daysmedian time to decision
246 days90th percentile
5clearances measured
FDA profile
- Official device name
- Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ULTepap Expiratory Positive Airway Pressure (EPAP) Device (K191728) | Bryggs Medical, LLC | 2020-02-21 |
| Bongo (K180619) | Innomed Healthscience, Inc. | 2018-08-16 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) (K102404) | Ventus Medical, Inc. | 2010-12-02 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (K090398) | Ventus Medical, Inc. | 2009-04-03 |
| PROVENT NASAL DILATOR, MODEL BR2 (K071560) | Ventus Medical, Inc. | 2008-02-08 |
Track OHP automatically
Every clearance here is in the API, with alerts when new ones post.