FDA 510(k) ear, nose and throat (ENT) devices cover diagnostic and therapeutic equipment used in otolaryngology. The FDA review panel code is EN.
This category includes:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 164d |
| All-time average (cleared) | 90d |
| Not Substantially Equivalent (denied) | 320d |
Recent Ear, Nose, Throat submissions have taken longer than the historical average - 164 days in the last 2 years vs 90 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 320 days before receiving a Not Substantially Equivalent determination.
This page lists all 3823 medical devices in the Ear, Nose, Throat specialty that have been submitted to the FDA through the 510(k) premarket notification process. Hearing aids, cochlear implants, ENT surgical instruments and endoscopes.
This page lists 3823 medical devices in the Ear, Nose, Throat specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 3806 were cleared as substantially equivalent to a predicate device. Average FDA review time: 90 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
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