Device, Inflation, Middle Ear
The Middle Ear Inflation Device is a device used to inflate or equalize pressure in the middle ear cavity, typically employed in the treatment of Eustachian tube dysfunction or middle ear effusion by delivering air or therapeutic agents through the Eustachian tube. It is classified as Unclassified (Class U), meaning the FDA has not yet made a final classification determination. No regulation number or medical specialty code is assigned, and it carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJV
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252751 | Earflo (EF001) | Feb 10, 2026 | Substantially Equivalent | Earflo, Inc. |
| K230502 | Ear Pressure Relief Device(Model:ER813B) | Jun 09, 2023 | Substantially Equivalent | Ningbo Albert Novosino Co., Ltd. |
| K203754 | Eustachi Ear Pressure Relief Device | Feb 19, 2021 | Substantially Equivalent | Exercore, LLC |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Mar 14, 2008 | Substantially Equivalent | Micromedics, Inc. |
| K951596 | EARCLEAR | May 24, 1995 | Substantially Equivalent | Arisil Medical |
| K920840 | OTOVENT | Oct 05, 1992 | Substantially Equivalent | Abigo Medical AB |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.