ETD · Class II · 21 CFR 874.3880

FDA Product Code ETD: Tube, Tympanostomy

Leading manufacturers include Exmoor Plastics , Ltd., Xomed, Inc. and Treace Medical, Inc..

116
Total
116
Cleared
85d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 3 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
1–24 of 116
Cleared Apr 23, 2026
Tula Tympanostomy Tube Delivery Device
K252436
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))
K250256
Aventamed Dac
Ear, Nose, Throat · 90d
Cleared May 20, 2024
Solo+ Tympanostomy Tube Device (TTD)
K232702
Aventamed Dac
Ear, Nose, Throat · 258d
Cleared Feb 16, 2024
Biowy Tym Tube (TT)
K233658
Biowy Corporation
Ear, Nose, Throat · 93d
Cleared Nov 24, 2023
Tympanostomy Tubes
K232059
Grace Medical, Inc.
Ear, Nose, Throat · 136d
Cleared Jul 27, 2022
Hummingbird Tympanostomy Tube System
K221254
Preceptis Medical, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 05, 2020
Hummingbird Tympanostomy Tube System
K200952
Preceptis Medical, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 28, 2017
TULA Tube Delivery System
K171239
Tusker Medical
Ear, Nose, Throat · 62d
Cleared Sep 21, 2015
Hummingbird Tympanostomy Tube
K151830
Preceptis Medical
Ear, Nose, Throat · 77d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067
Medtronic Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Apr 23, 2015
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K142282
Preceptis Medical
Ear, Nose, Throat · 251d
Cleared Aug 22, 2014
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921
Preceptis Medical
Ear, Nose, Throat · 242d
Cleared Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595
Acclarent, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 19, 2008
TYMPANOSTOMY TUBE
K082188
Acclarent, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
K000801
Gyrus Ent LLC
Ear, Nose, Throat · 98d
Cleared Aug 26, 1999
SILVERSTEIN MICROWICK
K991670
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 26, 1999
FLUOROPLASTIC VENTILATION TUBES
K992222
Gyrus Ent LLC
Ear, Nose, Throat · 56d
Cleared Oct 22, 1998
EXMOOR MYRINGOTOMY KIT
K980828
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 233d
Cleared Jul 15, 1998
TYMPANOSTOMY TUBE
K981575
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared May 13, 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 208d
Cleared Mar 23, 1998
ROUND WINDOW E-CATH
K973740
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 173d
Cleared Dec 12, 1997
SHAH PERMAVENT
K974007
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 52d
Cleared Nov 04, 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K973226
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 69d
Cleared Jul 29, 1997
MYRINGOTOMY TUBE
K972126
Mednet Locator, Inc.
Ear, Nose, Throat · 54d

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 3 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 →