FDA product code MJV: Device, Inflation, Middle Ear
MJV is the FDA product code for device, inflation, middle ear. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under MJV, 2 in the last five years, from 6 different applicants. The average 510(k) review took 117 days (median 103); 165 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Inflation, Middle Ear |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MJV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 58 |
| 2023 | 1 | 105 |
| 2026 | 1 | 165 |
Compare with all 510(k) review times · Search every MJV clearance
Top MJV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Earflo, Inc. | 1 | 2026-02-10 |
| Ningbo Albert Novosino Co., Ltd. | 1 | 2023-06-09 |
| Exercore, LLC | 1 | 2021-02-19 |
| Micromedics, Inc. | 1 | 2008-03-14 |
| Arisil Medical | 1 | 1995-05-24 |
1 more applicants have MJV clearances. See the full list in Caduvo.
Most recent MJV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252751 | Earflo, Inc. | Earflo (EF001) | 2026-02-10 | 165 |
| K230502 | Ningbo Albert Novosino Co., Ltd. | Ear Pressure Relief Device(Model:ER813B) | 2023-06-09 | 105 |
| K203754 | Exercore, LLC | Eustachi Ear Pressure Relief Device | 2021-02-19 | 58 |
| K073401 | Micromedics, Inc. | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | 2008-03-14 | 101 |
| K951596 | Arisil Medical | EARCLEAR | 1995-05-24 | 47 |
Recalls for MJV devices
openFDA lists no recalls for product code MJV.
Frequently asked questions
What is FDA product code MJV?
MJV is the FDA product code for device, inflation, middle ear. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is MJV?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJV?
Across 6 cleared submissions the average was 117 days from receipt to decision (median 103).
Which companies have the most MJV clearances?
Earflo, Inc. (1); Ningbo Albert Novosino Co., Ltd. (1); Exercore, LLC (1); Micromedics, Inc. (1); Arisil Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJV
- Run a recall and safety report across every MJV manufacturer
- Watch product code MJV 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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