Product Code: ETD FDA class 2 21 CFR 874.3880

Tube, Tympanostomy

Ear, Nose, Throat

The tympanostomy tube (also known as a pressure equalization tube) is a small implantable device surgically inserted through the tympanic membrane to ventilate the middle ear, relieve fluid accumulation, and reduce recurrent ear infections in patients with chronic otitis media with effusion. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ETD, regulated under 21 CFR 874.3880 in the Ear, Nose, Throat specialty. This device is designated as an implant.

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510(k)s

116

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ETD
Device Class: FDA class 2
Regulation Number: 874.3880
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 116 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252436	Tula Tympanostomy Tube Delivery Device	Apr 23, 2026	Substantially Equivalent	Tusker Medical, Inc.
K250256	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))	Apr 28, 2025	Substantially Equivalent	Aventamed Dac
K232702	Solo+ Tympanostomy Tube Device (TTD)	May 20, 2024	Substantially Equivalent	Aventamed Dac
K233658	Biowy Tym Tube (TT)	Feb 16, 2024	Substantially Equivalent	Biowy Corporation
K232059	Tympanostomy Tubes	Nov 24, 2023	Substantially Equivalent	Grace Medical, Inc.
K221254	Hummingbird Tympanostomy Tube System	Jul 27, 2022	Substantially Equivalent	Preceptis Medical, Inc.
K200952	Hummingbird Tympanostomy Tube System	Jun 05, 2020	Substantially Equivalent	Preceptis Medical, Inc.
K171239	TULA Tube Delivery System	Jun 28, 2017	Substantially Equivalent	Tusker Medical
K151830	Hummingbird Tympanostomy Tube	Sep 21, 2015	Substantially Equivalent	Preceptis Medical
K151067	Ventilation (Tympanostomy) Tubes	Jul 22, 2015	Substantially Equivalent	Medtronic Xomed, Inc.
K142282	HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)	Apr 23, 2015	Substantially Equivalent	Preceptis Medical
K133921	PRECEPTIS TYMPANOSTOMY TUBE INSERTER	Aug 22, 2014	Substantially Equivalent	Preceptis Medical
K103595	ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM	Apr 01, 2011	Substantially Equivalent	Acclarent, Inc.
K082188	TYMPANOSTOMY TUBE	Sep 19, 2008	Substantially Equivalent	Acclarent, Inc.
K071150	TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE	Dec 12, 2007	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K071178	OTOMEDICS SOFT TYMPANOSTOMY TUBE	Jun 22, 2007	Substantially Equivalent	Otomedics Advanced Medical Technologies, Ltd.
K062672	GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES	Oct 24, 2006	Substantially Equivalent	Grace Medical, Inc.
K062385	BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES	Sep 27, 2006	Substantially Equivalent	Grace Medical, Inc.
K061058	NEOZOLINE VENTILATION TUBES	Jul 12, 2006	Substantially Equivalent	Adept Medical, Ltd.
K011383	MICRODOSE CATH, MODELS 90121-201, -202, -203	Jun 25, 2001	Substantially Equivalent	Durect Corp.
K000801	PC COATED FLUOROPLASTIC VENT TUBES	Jun 19, 2000	Substantially Equivalent	Gyrus Ent LLC
K992222	FLUOROPLASTIC VENTILATION TUBES	Aug 26, 1999	Substantially Equivalent	Gyrus Ent LLC
K991670	SILVERSTEIN MICROWICK	Aug 26, 1999	Substantially Equivalent	Micromedics, Inc.
K980828	EXMOOR MYRINGOTOMY KIT	Oct 22, 1998	Substantially Equivalent	Exmoor Plastics , Ltd.
K981575	TYMPANOSTOMY TUBE	Jul 15, 1998	Substantially Equivalent	Grace Medical, Inc.
K974008	PFLEIDERER'S INTRATYMPANIC CATHETER	May 13, 1998	Substantially Equivalent	Exmoor Plastics , Ltd.
K973740	ROUND WINDOW E-CATH	Mar 23, 1998	Substantially Equivalent	Neuro-Biometrix, Inc.
K974007	SHAH PERMAVENT	Dec 12, 1997	Substantially Equivalent	Exmoor Plastics , Ltd.
K973226	TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)	Nov 04, 1997	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K972126	MYRINGOTOMY TUBE	Jul 29, 1997	Substantially Equivalent	Mednet Locator, Inc.
K972400	MYRINGOTOMY TUBE - BOBBIN WITH TAB	Jul 23, 1997	Substantially Equivalent	Mednet Locator, Inc.
K971943	MYRINGOTOMY TUBE	Jul 23, 1997	Substantially Equivalent	Mednet Locator, Inc.
K971454	TYMPANOSTOMY VENTILATION TUBE	May 29, 1997	Substantially Equivalent	Ikonos Corp.
K971124	TM MICRO-CATHETERS	May 16, 1997	Substantially Equivalent	Xomed, Inc.
K965115	ROUND WINDOW CATH	Mar 10, 1997	Substantially Equivalent	Neuro-Biometrix, Inc.
K963727	HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER	Feb 11, 1997	Substantially Equivalent	Medtronic Xomed
K961873	ACTIVENT ANTIMICROBIAL VENTILATION TUBES	Jul 01, 1996	Substantially Equivalent	Xomed, Inc.
K961945	TYMPANOSTOMY VENTILATION TUBE	Jun 11, 1996	Substantially Equivalent	Advanced Microbotics Corp.
K960742	TYMPANOSTOMY VENTILATION TUBE	Apr 03, 1996	Substantially Equivalent	Advanced Microbotics Corp.
K960477	VENTILATION TUBES	Feb 26, 1996	Substantially Equivalent	Smith & Nephew, Inc.
K955616	MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE	Jan 17, 1996	Substantially Equivalent	Misten Medical Corp.
K955447	TYMPANOSTOMY TUBE	Dec 21, 1995	Substantially Equivalent	Trebay Medical Corp.
K954795	AT2 & DOYLE STYLE (C-FLEX) VENT TUBES	Nov 15, 1995	Substantially Equivalent	Trebay Medical Corp.
K953802	TYMPANOSTOMY TUBE	Oct 24, 1995	Substantially Equivalent	Bluff City Medical Technologies, Inc.
K953993	TYMPASNOSTOMY TUBE	Sep 12, 1995	Substantially Equivalent	Hampton Precision Products, Inc.
K941407	TYMPANOSTOMY (VENTILATION) TUBE	Mar 14, 1995	Substantially Equivalent	Xomed-Treace, Inc.
K943325	TYMPANOSTOMY TUBE	Oct 11, 1994	Substantially Equivalent	Grace Medical, Inc.
K943848	COLLAR BUTTON VENTURI VENT TUBE	Sep 16, 1994	Substantially Equivalent	Micromed Development Corp.
K943849	GROMMENT STYLE VENTURI TUBE	Sep 02, 1994	Substantially Equivalent	Micromed Development Corp.
K943847	BOBBIN STYLE VENTURI VENT TUBE	Sep 02, 1994	Substantially Equivalent	Micromed Development Corp.
K943281	POLYETHYLENE VENT TUBES	Aug 24, 1994	Substantially Equivalent	Micromed Development Corp.
K943190	C-FLEX VENT TUBES	Aug 24, 1994	Substantially Equivalent	Micromed Development Corp.
K936275	TYMPOVENT	May 05, 1994	Substantially Equivalent	Atos Medical AB
K932166	SILICONE TYMPANOSTOMY TUBES	Jul 26, 1993	Substantially Equivalent	Smith & Nephew Richards, Inc.
K923353	VENTILATION TUBES W/ HYDROGEL COATING	May 18, 1993	Substantially Equivalent	Microbio-Medics, Inc.
K926462	BEL-AIR VENTILATION TUBE	May 05, 1993	Substantially Equivalent	Exmoor Plastics , Ltd.
K923887	JACK'S VENT TUBES	Feb 19, 1993	Substantially Equivalent	O.R. Specialties, Inc.
K921923	TITANIUM VENTILATION TUBES	Feb 12, 1993	Substantially Equivalent	Exmoor Plastics , Ltd.
K911580	DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES	Sep 24, 1991	Substantially Equivalent	Exmoor Plastics , Ltd.
K910618	SUH VENT TUBE	Jun 28, 1991	Substantially Equivalent	Boston Medical Products, Inc.
K904597	GROMMET STYLE VENTURI	Jan 28, 1991	Substantially Equivalent	River Medical, Inc.
K904594	COLLAR BUTTON STYLE VENTURI	Jan 28, 1991	Substantially Equivalent	River Medical, Inc.
K904592	BOBBIN STYLE VENTURI	Jan 28, 1991	Substantially Equivalent	River Medical, Inc.
K903285	MICRO BRIGHT VENTILATION TUBES	Sep 26, 1990	Substantially Equivalent	Invotec International, Inc.
K900267	JAHN VENTILATION TUBE	Jun 14, 1990	Substantially Equivalent	Smith & Nephew Richards, Inc.
K895242	PAPPAS TRI-FLANGE VENTILATION TUBE	Nov 17, 1989	Substantially Equivalent	Richards Medical Co., Inc.
K883667	DONALDSON VENTILATION TUBES PT. # AG/S9	Nov 14, 1988	Substantially Equivalent	Exmoor Plastics , Ltd.
K882689	PUNCH MYRINGOTOMY SYSTEM	Sep 13, 1988	Substantially Equivalent	Xomed, Inc.
K870877	BIO-VENT REUTER BOBBIN TUBE	Mar 26, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K871035	'EXMOOR' T-TUBE	Mar 23, 1987	Substantially Equivalent	Exmoor Plastics , Ltd.
K870129	VENTILATION TUBES WITH HYDROGEL COATING	Feb 10, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K853641	GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE	Jan 06, 1986	Substantially Equivalent	Xomed, Inc.
K852387	GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE	Jan 06, 1986	Substantially Equivalent	Xomed, Inc.
K833246	TYMPANOSTOMY TUBES-VARIOUS	Jan 04, 1985	Substantially Equivalent	Abco Dealers, Inc.
K842637	UNIFLOW VENT TUBE	Oct 25, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K833910	TSH RIA	Nov 22, 1983	Substantially Equivalent	Syncor Intl. Corp.
K823910	DONALDSON VENT TUBE	Nov 22, 1983	Substantially Equivalent	Treace Medical, Inc.
K833909	VENTRESCREEN BETA-HCG ENZYME IMMUNO	Nov 21, 1983	Substantially Equivalent	Vxr, Inc.
K832362	DONALDSON-TYPE VENT TUBE	Oct 14, 1983	Substantially Equivalent	Concept, Inc.
K832361	CONCEPT T-TUBE	Oct 14, 1983	Substantially Equivalent	Concept, Inc.
K830584	SOILEAU TYTAN BOBBIN VENT TUBE	Jun 02, 1983	Substantially Equivalent	Treace Medical, Inc.
K823909	T-TUBE VENT TUBE	Mar 17, 1983	Substantially Equivalent	Treace Medical, Inc.
K830228	OTOLOGICAL VENTILATION TUBES-VARIOUS	Mar 07, 1983	Substantially Equivalent	Micromedics, Inc.
K830085	COLLAR BUTTON VENT TUBE	Jan 28, 1983	Substantially Equivalent	Treace Medical, Inc.
K823908	GROMMET VENT TUBE	Jan 28, 1983	Substantially Equivalent	Treace Medical, Inc.
K823907	COLLAR BUTTON VENT TUBE	Jan 28, 1983	Substantially Equivalent	Treace Medical, Inc.
K822017	TYMPANOSTOMY TUBES & VARIOUS TYPES	Oct 27, 1982	Substantially Equivalent	Kelleher Corp.
K822376	TYTAN REUTER BOBBIN VENT TUBE	Sep 09, 1982	Substantially Equivalent	Treace Medical, Inc.
K822375	ARMSTRONG V VENT TUBE	Sep 09, 1982	Substantially Equivalent	Treace Medical, Inc.
K822366	TYTAN GROMMET VENT TUBE, .040	Sep 02, 1982	Substantially Equivalent	Treace Medical, Inc.
K820510	TYMPANOSTOMY TUBES (VARIOUS MODELS	Mar 19, 1982	Substantially Equivalent	Abco Dist.
K820362	REUTER BOBBIN VENTILA. TUBE-TITANIUM	Mar 02, 1982	Substantially Equivalent	Richard'S Medical Equip., Inc.
K813616	TEKNA MED MYRINGOTOMY DISPOS-OTO KIT	Jan 22, 1982	Substantially Equivalent	Humboldt Products
K812459	EXMOOR AURAL GROMMET AG/TI	Sep 25, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K812460	VARIOUS AURAL GROMMETS	Sep 21, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K811698	CARL ZEISS INN MYRINGOTOMY TUBE LINE	Aug 31, 1981	Substantially Equivalent	James L. Geraci & Associates, Inc.
K810706	EXMOOR AURAL GROMMET AG/T5	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K810705	EXMOOR AURAL GROMMET AG/T4	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K810704	EXMOOR AURAL GROMMET AG/T3	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K810703	EXMOOR AURAL GROMMET AG/T2	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K810702	EXMOOR AURAL GROMMET AG/T2L	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K810701	EXMOOR AURAL GROMMET	Apr 14, 1981	Substantially Equivalent	Exmoor Plastics , Ltd.
K802638	OTOLOGICAL VENTILATION TUBES	Nov 12, 1980	Substantially Equivalent	Santa Barbara Medco, Inc.
K802587	OTOLOGICAL VENTILATION TUBES	Nov 12, 1980	Substantially Equivalent	Humboldt Products
K800728	PAPARELL TYPE 2, BIOLITE COATED SILI-	Apr 16, 1980	Substantially Equivalent	Xomed, Inc.
K800727	GOODE T-TUBE, BIOLITE COATED SILICONE/TU	Apr 16, 1980	Substantially Equivalent	Xomed, Inc.
K791680	POPE UMBRELLA TUBE	Nov 13, 1979	Substantially Equivalent	Xomed, Inc.
K790216	VENTILATION TUBE, SHEEHY COLLAT	Feb 12, 1979	Substantially Equivalent	Xomed, Inc.
K781260	VENTILATION TUBE SILICONE PAPARELLA TYPE	Aug 14, 1978	Substantially Equivalent	Xomed, Inc.
K781259	VENTILATION TUBE TEFLON SHEPARD TYPE	Aug 14, 1978	Substantially Equivalent	Xomed, Inc.
K781258	VENTILATION TUBE. SILI. DONALDSON TYPE	Aug 14, 1978	Substantially Equivalent	Xomed, Inc.
K781257	VENTILATION TUBE SILI. SHEPPARD TYPE	Aug 14, 1978	Substantially Equivalent	Xomed, Inc.
K780956	OTOLOGICAL VENTILATION TUBES	Jun 22, 1978	Substantially Equivalent	Mcghan Medical Corp.
K772066	PULLEN PLASTIC-PORE PLUGS	Dec 20, 1977	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760439	PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY	Sep 27, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760438	SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY	Sep 21, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.