FDA 510(k) Ear, Nose & Throat Devices
About Ear, Nose, Throat Devices
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:
- Hearing aids and amplifiers - air conduction, bone conduction and CROS systems
- Cochlear implants - Class III devices (typically PMA, some 510k predicate paths)
- ENT endoscopes - rigid and flexible nasopharyngoscopes, laryngoscopes
- Surgical instruments - microdebriders, powered ENT systems
- Audiometric systems - audiometers, tympanometers, OAE devices
FDA 510(k) Cleared Ear, Nose, Throat Devices
This page lists all 3791 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.
- 3774 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 89 days.
- Records available from 1976 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 3791 medical devices in the Ear, Nose, Throat specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 3774 were cleared as substantially equivalent to a predicate device. Average FDA review time: 89 days. Records from 1976 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to ear, nose, throat
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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.
Looking for a specific ear, nose, throat device? Search by device name, K-number or manufacturer.
Search all Ear, Nose, Throat 510(k) devices