Tube, Tympanostomy
FDA product code ETD · Class II (moderate risk) · 21 CFR 874.3880 · Ear, Nose, Throat
116510(k) clearances
0PMA approvals
14recalls
Implantimplanted device
Manufacturers
- Exmoor Plastics , Ltd. 16
- Xomed, Inc. 13
- Treace Medical, Inc. 9
- Micromed Development Corp. 5
- Grace Medical, Inc. 5
- Preceptis Medical 5
- Richard'S Medical Equip., Inc. 4
- Richards Medical Co., Inc. 4
- River Medical, Inc. 3
- Mednet Locator, Inc. 3
- Micromedics, Inc. 2
- Neuro-Biometrix, Inc. 2
- Smith & Nephew Richards, Inc. 2
- Aventamed Dac 2
- Gyrus Ent LLC 2
- Concept, Inc. 2
- Medtronic Xomed, Inc. 2
- Heinz Kurz GmbH Medizintechnik 2
- Acclarent, Inc. 2
- Humboldt Products 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery DeviceETD · Traditional | Tusker Medical, Inc. | 04/23/2026SE |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional | Aventamed Dac | 04/28/2025SE |
| K232702 | Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional | Aventamed Dac | 05/20/2024SE |
| K233658 | Biowy Tym Tube (TT)ETD · Traditional | Biowy Corporation | 02/16/2024SE |
| K232059 | Tympanostomy TubesETD · Traditional | Grace Medical, Inc. | 11/24/2023SE |
| K221254 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 07/27/2022SE |
| K200952 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 06/05/2020SE |
| K171239 | TULA Tube Delivery SystemETD · Special | Tusker Medical | 06/28/2017SE |
| K151830 | Hummingbird Tympanostomy TubeETD · Traditional | Preceptis Medical | 09/21/2015SE |
| K151067 | Ventilation (Tympanostomy) TubesETD · Traditional | Medtronic Xomed, Inc. | 07/22/2015SE |
| K142282 | Hummingbird(Tm) Tympanostomy Tube System (TTS)ETD · Traditional | Preceptis Medical | 04/23/2015SE |
| K133921 | Preceptis Tympanostomy Tube InserterETD · Traditional | Preceptis Medical | 08/22/2014SE |
| K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemETD · Traditional | Acclarent, Inc. | 04/01/2011SE |
| K082188 | Tympanostomy TubeETD · Traditional | Acclarent, Inc. | 09/19/2008SE |
| K071150 | Trocar Ventilation Tube/With Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015…ETD · Traditional | Heinz Kurz GmbH Medizintechnik | 12/12/2007SE |
| K071178 | Otomedics Soft Tympanostomy TubeETD · Traditional | Otomedics Advanced Medical Technologies, Ltd. | 06/22/2007SE |
| K062672 | Grace Medical PC Coated Tympanostomy TubesETD · Traditional | Grace Medical, Inc. | 10/24/2006SE |
| K062385 | Blue PTFE (Fluoroplastic) Ventilation TubesETD · Traditional | Grace Medical, Inc. | 09/27/2006SE |
| K061058 | Neozoline Ventilation TubesETD · Traditional | Adept Medical, Ltd. | 07/12/2006SE |
| K011383 | Microdose Cath, Models 90121-201, -202, -203ETD · Special | Durect Corp. | 06/25/2001SE |
| K000801 | PC Coated Fluoroplastic Vent TubesETD · Traditional | Gyrus Ent LLC | 06/19/2000SE |
| K992222 | Fluoroplastic Ventilation TubesETD · Traditional | Gyrus Ent LLC | 08/26/1999SE |
| K991670 | Silverstein MicrowickETD · Traditional | Micromedics, Inc. | 08/26/1999SE |
| K980828 | Exmoor Myringotomy KitETD · Traditional | Exmoor Plastics , Ltd. | 10/22/1998SE |
| K981575 | Tympanostomy TubeETD · Traditional | Grace Medical, Inc. | 07/15/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | Exmoor Plastics , Ltd. | 05/13/1998SE |
| K973740 | Round Window E-CathETD · Traditional | Neuro-Biometrix, Inc. | 03/23/1998SE |
| K974007 | Shah PermaventETD · Traditional | Exmoor Plastics , Ltd. | 12/12/1997SE |
| K973226 | Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo…ETD · Traditional | Heinz Kurz GmbH Medizintechnik | 11/04/1997SE |
| K972126 | Myringotomy TubeETD · Traditional | Mednet Locator, Inc. | 07/29/1997SE |
| K972400 | Myringotomy Tube - Bobbin with TabETD · Traditional | Mednet Locator, Inc. | 07/23/1997SE |
| K971943 | Myringotomy TubeETD · Traditional | Mednet Locator, Inc. | 07/23/1997SE |
| K971454 | Tympanostomy Ventilation TubeETD · Traditional | Ikonos Corp. | 05/29/1997SE |
| K971124 | TM Micro-CathetersETD · Traditional | Xomed, Inc. | 05/16/1997SE |
| K965115 | Round Window CathETD · Traditional | Neuro-Biometrix, Inc. | 03/10/1997SE |
| K963727 | Hoffman H/A Coated Long-Term Ventilation Tube with LinerETD · Traditional | Medtronic Xomed | 02/11/1997SE |
| K961873 | Activent Antimicrobial Ventilation TubesETD · Traditional | Xomed, Inc. | 07/01/1996SE |
| K961945 | Tympanostomy Ventilation TubeETD · Traditional | Advanced Microbotics Corp. | 06/11/1996SE |
| K960742 | Tympanostomy Ventilation TubeETD · Traditional | Advanced Microbotics Corp. | 04/03/1996SE |
| K960477 | Ventilation TubesETD · Traditional | Smith & Nephew, Inc. | 02/26/1996SE |
| K955616 | Misten Medical Reuter Bobbin Style Vent TubeETD · Traditional | Misten Medical Corp. | 01/17/1996SE |
| K955447 | Tympanostomy TubeETD · Traditional | Trebay Medical Corp. | 12/21/1995SE |
| K954795 | AT2 & Doyle Style (C-Flex) Vent TubesETD · Traditional | Trebay Medical Corp. | 11/15/1995SE |
| K953802 | Tympanostomy TubeETD · Traditional | Bluff City Medical Technologies, Inc. | 10/24/1995SE |
| K953993 | Tympasnostomy TubeETD · Traditional | Hampton Precision Products, Inc. | 09/12/1995SE |
| K941407 | Tympanostomy (Ventilation) TubeETD · Traditional | Xomed-Treace, Inc. | 03/14/1995SE |
| K943325 | Tympanostomy TubeETD · Traditional | Grace Medical, Inc. | 10/11/1994SE |
| K943848 | Collar Button Venturi Vent TubeETD · Traditional | Micromed Development Corp. | 09/16/1994SE |
| K943849 | Gromment Style Venturi TubeETD · Traditional | Micromed Development Corp. | 09/02/1994SE |
| K943847 | Bobbin Style Venturi Vent TubeETD · Traditional | Micromed Development Corp. | 09/02/1994SE |
| K943281 | Polyethylene Vent TubesETD · Traditional | Micromed Development Corp. | 08/24/1994SE |
| K943190 | C-Flex Vent TubesETD · Traditional | Micromed Development Corp. | 08/24/1994SE |
| K936275 | TympoventETD · Traditional | Atos Medical AB | 05/05/1994SE |
| K932166 | Silicone Tympanostomy TubesETD · Traditional | Smith & Nephew Richards, Inc. | 07/26/1993SE |
| K923353 | Ventilation Tubes W/ Hydrogel CoatingETD · Traditional | Microbio-Medics, Inc. | 05/18/1993SE |
| K926462 | Bel-Air Ventilation TubeETD · Traditional | Exmoor Plastics , Ltd. | 05/05/1993SE |
| K923887 | Jack's Vent TubesETD · Traditional | O.R. Specialties, Inc. | 02/19/1993SE |
| K921923 | Titanium Ventilation TubesETD · Traditional | Exmoor Plastics , Ltd. | 02/12/1993SE |
| K911580 | Donaldson/Shepards Dr/Collar/Shah Vent-Mini TubesETD · Traditional | Exmoor Plastics , Ltd. | 09/24/1991SE |
| K910618 | Suh Vent TubeETD · Traditional | Boston Medical Products, Inc. | 06/28/1991SE |
| K904597 | Grommet Style VenturiETD · Traditional | River Medical, Inc. | 01/28/1991SE |
| K904594 | Collar Button Style VenturiETD · Traditional | River Medical, Inc. | 01/28/1991SE |
| K904592 | Bobbin Style VenturiETD · Traditional | River Medical, Inc. | 01/28/1991SE |
| K903285 | Micro Bright Ventilation TubesETD · Traditional | Invotec International, Inc. | 09/26/1990SE |
| K900267 | Jahn Ventilation TubeETD · Traditional | Smith & Nephew Richards, Inc. | 06/14/1990SE |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | Richards Medical Co., Inc. | 11/17/1989SE |
| K883667 | Donaldson Ventilation Tubes Pt. # AG/S9ETD · Traditional | Exmoor Plastics , Ltd. | 11/14/1988SE |
| K882689 | Punch Myringotomy SystemETD · Traditional | Xomed, Inc. | 09/13/1988SE |
| K870877 | Bio-Vent Reuter Bobbin TubeETD · Traditional | Richards Medical Co., Inc. | 03/26/1987SE |
| K871035 | 'Exmoor' T-TubeETD · Traditional | Exmoor Plastics , Ltd. | 03/23/1987SE |
| K870129 | Ventilation Tubes with Hydrogel CoatingETD · Traditional | Richards Medical Co., Inc. | 02/10/1987SE |
| K853641 | Godde T-Tube Blue Silicone Tympanostomy TubeETD · Traditional | Xomed, Inc. | 01/06/1986SE |
| K852387 | Goode T-Tube White Silicone Tympanostomy TubeETD · Traditional | Xomed, Inc. | 01/06/1986SE |
| K833246 | Tympanostomy Tubes-VariousETD · Traditional | Abco Dealers, Inc. | 01/04/1985SE |
| K842637 | Uniflow Vent TubeETD · Traditional | Richards Medical Co., Inc. | 10/25/1984SE |
| K833910 | TSH RiaETD · Traditional | Syncor Intl. Corp. | 11/22/1983SE |
| K823910 | Donaldson Vent TubeETD · Traditional | Treace Medical, Inc. | 11/22/1983SE |
| K833909 | Ventrescreen Beta-Hcg Enzyme ImmunoETD · Traditional | Vxr, Inc. | 11/21/1983SE |
| K832362 | Donaldson-Type Vent TubeETD · Traditional | Concept, Inc. | 10/14/1983SE |
| K832361 | Concept T-TubeETD · Traditional | Concept, Inc. | 10/14/1983SE |
| K830584 | Soileau Tytan Bobbin Vent TubeETD · Traditional | Treace Medical, Inc. | 06/02/1983SE |
| K823909 | T-Tube Vent TubeETD · Traditional | Treace Medical, Inc. | 03/17/1983SE |
| K830228 | Otological Ventilation Tubes-VariousETD · Traditional | Micromedics, Inc. | 03/07/1983SE |
| K830085 | Collar Button Vent TubeETD · Traditional | Treace Medical, Inc. | 01/28/1983SE |
| K823908 | Grommet Vent TubeETD · Traditional | Treace Medical, Inc. | 01/28/1983SE |
| K823907 | Collar Button Vent TubeETD · Traditional | Treace Medical, Inc. | 01/28/1983SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | Kelleher Corp. | 10/27/1982SE |
| K822376 | Tytan Reuter Bobbin Vent TubeETD · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822375 | Armstrong V Vent TubeETD · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822366 | Tytan Grommet Vent Tube, .040ETD · Traditional | Treace Medical, Inc. | 09/02/1982SE |
| K820510 | Tympanostomy Tubes (Various ModelsETD · Traditional | Abco Dist. | 03/19/1982SE |
| K820362 | Reuter Bobbin Ventila. Tube-TitaniumETD · Traditional | Richard'S Medical Equip., Inc. | 03/02/1982SE |
| K813616 | Tekna Med Myringotomy Dispos-Oto KitETD · Traditional | Humboldt Products | 01/22/1982SE |
| K812459 | Exmoor Aural Grommet Ag/TiETD · Traditional | Exmoor Plastics , Ltd. | 09/25/1981SE |
| K812460 | Various Aural GrommetsETD · Traditional | Exmoor Plastics , Ltd. | 09/21/1981SE |
| K811698 | Carl Zeiss Inn Myringotomy Tube LineETD · Traditional | James L. Geraci & Associates, Inc. | 08/31/1981SE |
| K810706 | Exmoor Aural Grommet AG/T5ETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K810705 | Exmoor Aural Grommet AG/T4ETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K810704 | Exmoor Aural Grommet AG/T3ETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K810703 | Exmoor Aural Grommet AG/T2ETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K810702 | Exmoor Aural Grommet AG/T2LETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K810701 | Exmoor Aural GrommetETD · Traditional | Exmoor Plastics , Ltd. | 04/14/1981SE |
| K802638 | Otological Ventilation TubesETD · Traditional | Santa Barbara Medco, Inc. | 11/12/1980SE |
| K802587 | Otological Ventilation TubesETD · Traditional | Humboldt Products | 11/12/1980SE |
| K800728 | Paparell Type 2, Biolite Coated Sili-ETD · Traditional | Xomed, Inc. | 04/16/1980SE |
| K800727 | Goode T-Tube, Biolite Coated Silicone/TuETD · Traditional | Xomed, Inc. | 04/16/1980SE |
| K791680 | Pope Umbrella TubeETD · Traditional | Xomed, Inc. | 11/13/1979SE |
| K790216 | Ventilation Tube, Sheehy CollatETD · Traditional | Xomed, Inc. | 02/12/1979SE |
| K781260 | Ventilation Tube Silicone Paparella TypeETD · Traditional | Xomed, Inc. | 08/14/1978SE |
| K781259 | Ventilation Tube Teflon Shepard TypeETD · Traditional | Xomed, Inc. | 08/14/1978SE |
| K781258 | Ventilation Tube. Sili. Donaldson TypeETD · Traditional | Xomed, Inc. | 08/14/1978SE |
| K781257 | Ventilation Tube Sili. Sheppard TypeETD · Traditional | Xomed, Inc. | 08/14/1978SE |
| K780956 | Otological Ventilation TubesETD · Traditional | Mcghan Medical Corp. | 06/22/1978SE |
| K772066 | Pullen Plastic-Pore PlugsETD · Traditional | Richard'S Medical Equip., Inc. | 12/20/1977SE |
| K760439 | Plasti-Pore Bobbin Drain Tube, OtologyETD · Traditional | Richard'S Medical Equip., Inc. | 09/27/1976SE |
| K760438 | Spoon-Bobbin Drain Tube W/ Wire, OtologyETD · Traditional | Richard'S Medical Equip., Inc. | 09/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0970-2025 Class II | Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0969-2025 Class II | Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0968-2025 Class II | Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0967-2025 Class II | Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0966-2025 Class II | Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0965-2025 Class II | Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0964-2025 Class II | Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0963-2025 Class II | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;Lack of 510(k) clearance. | Adept Medical Ltd | 11/24/2024Open, Classified |
| Z-0707-2025 Class II | Duravent Silicone Ventilation Tube. Model Number: 240075.Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny… | Olympus Corporation of the Americas | 11/19/2024Open, Classified |
| Z-1004-2024 Class II | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the…The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly… | Olympus Corporation of the Americas | 12/11/2023Open, Classified |
| Z-1731-2014 Class II | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01…One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes… | Summit Medical, Inc. | 05/12/2014Terminated |
| Z-0411-2013 Class II | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO…One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene… | Gyrus Acmi, Incorporated | 10/17/2012Terminated |
| Z-0348-2011 | VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | Micromedics, Inc. | 03/15/2010Terminated |
| Z-0797-2010 | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO…Units of the product in lot MH136952 may have been shipped without being sterilized. | Gyrus ACMI Corporation | 01/08/2010Terminated |