Otovent® 50105
Otovent 50105 is a middle ear decompressor (FDA unclassified; FDA product code MJV, Device, Inflation, Middle Ear) made by Circius Pharma AB, cleared under FDA 510(k) K920840 on 5 Oct 1992 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 07350133960232), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350133960232 | Date20 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK920840 | Date5 Oct 1992 | StatusActive |
Official records
- AccessGUDID record 07350133960232
- FDA 510(k) database K920840
Across registries
- FDA 510(k) K920840 decided 5 Oct 1992 Active
- FDA GUDID UDI-DI 07350133960232 listed 20 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K920840
- Listed FDA GUDID 07350133960232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Otovent®
- Generic name
- Middle ear decompressor, positive pressure
- Model / reference
- 50105
- Description
- Treatment of negative pressure in the middle ear. Otovent® can be used by adults and in children aged 3 years and up. 1 nose piece 1 balloon
- Primary DI / UDI-DI
- 07350133960232
- 510(k) Number
- FDA product code
- MJV
- GMDN term
- Middle ear decompressor, positive pressure
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MJV (Device, Inflation, Middle Ear).
- EARCLEAR by Arisil Medical
- Earflo (EF001) by Earflo, Inc.
- Ear Pressure Relief Device(Model:ER813B) by Ningbo Albert Novosino Co.,Ltd.
- EP-2100A by Summit Medical, LLC
- EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 by Micromedics, Inc.
- OTOVENT by ABIGO Medical AB
- Eustachi Ear Pressure Relief Device by Exercore, LLC