FDA Product Code ETD: Tube, Tympanostomy
Leading manufacturers include Preceptis Medical, Inc., Aventamed Dac and Grace Medical, Inc..
116
Total
116
Cleared
85d
Avg days
1976
Since
Declining activity -
2 submissions in the last 2 years
vs 4 in the prior period
Review times increasing: avg
178d
recently vs 84d historically
FDA 510(k) Cleared Tube, Tympanostomy Devices (Product Code ETD)
116 devices
Cleared
Apr 23, 2026
Tula Tympanostomy Tube Delivery Device
Tusker Medical, Inc.
Ear, Nose, Throat
265d
Cleared
Apr 28, 2025
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
Aventamed Dac
Ear, Nose, Throat
90d
Cleared
May 20, 2024
Solo+ Tympanostomy Tube Device (TTD)
Aventamed Dac
Ear, Nose, Throat
258d
Cleared
Feb 16, 2024
Biowy Tym Tube (TT)
Biowy Corporation
Ear, Nose, Throat
93d
Cleared
Nov 24, 2023
Tympanostomy Tubes
Grace Medical, Inc.
Ear, Nose, Throat
136d
Cleared
Jul 27, 2022
Hummingbird Tympanostomy Tube System
Preceptis Medical, Inc.
Ear, Nose, Throat
86d
Cleared
Jun 05, 2020
Hummingbird Tympanostomy Tube System
Preceptis Medical, Inc.
Ear, Nose, Throat
57d
Cleared
Feb 26, 1996
VENTILATION TUBES
Smith & Nephew, Inc.
Ear, Nose, Throat
25d
About Product Code ETD - Regulatory Context
510(k) Submission Activity
116 total 510(k) submissions under product code ETD since 1976, with 116 receiving FDA clearance (average review time: 85 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - ETD Product Code
Recent submissions under ETD have taken an average of 178 days to reach a decision - up from 84 days historically. Manufacturers should account for longer review timelines in current project planning.
ETD devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →