FDA Product Code MJV: Device, Inflation, Middle Ear
Leading manufacturers include Earflo, Inc., Exercore, LLC and Ningbo Albert Novosino Co., Ltd..
6
Total
6
Cleared
117d
Avg days
1992
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
165d
recently vs 107d historically
FDA 510(k) Cleared Device, Inflation, Middle Ear Devices (Product Code MJV)
6 devices
Cleared
Feb 10, 2026
Earflo (EF001)
Earflo, Inc.
Ear, Nose, Throat
165d
Cleared
Jun 09, 2023
Ear Pressure Relief Device(Model:ER813B)
Ningbo Albert Novosino Co., Ltd.
Ear, Nose, Throat
105d
Cleared
Feb 19, 2021
Eustachi Ear Pressure Relief Device
Exercore, LLC
Ear, Nose, Throat
58d
About Product Code MJV - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code MJV since 1992, with 6 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - MJV Product Code
Recent submissions under MJV have taken an average of 165 days to reach a decision - up from 107 days historically. Manufacturers should account for longer review timelines in current project planning.
MJV devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →