Atlas FDA

ETD

116 FDA 510(k) clearances · Product code

56 daysmedian time to decision
215 days90th percentile
116clearances measured

FDA profile

Official device name
Tube, Tympanostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3880
Medical specialty
Ear, Nose, Throat
Flags
Implant
Adverse events (MAUDE)
2001: 5 · 2002: 3 · 2003: 4 · 2010: 4 · 2013: 7 · 2019: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Tula Tympanostomy Tube Delivery Device (K252436)Tusker Medical, Inc.2026-04-23
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 Dac2025-04-28
Solo+ Tympanostomy Tube Device (TTD) (K232702)Aventamed Dac2024-05-20
Biowy Tym Tube (TT) (K233658)Biowy Corporation2024-02-16
Tympanostomy Tubes (K232059)Grace Medical, Inc.2023-11-24
Hummingbird Tympanostomy Tube System (K221254)Preceptis Medical, Inc.2022-07-27
Hummingbird Tympanostomy Tube System (K200952)Preceptis Medical, Inc.2020-06-05
TULA Tube Delivery System (K171239)Tusker Medical2017-06-28
Hummingbird Tympanostomy Tube (K151830)Preceptis Medical2015-09-21
Ventilation (Tympanostomy) Tubes (K151067)Medtronic Xomed, Inc.2015-07-22
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (K142282)Preceptis Medical2015-04-23
PRECEPTIS TYMPANOSTOMY TUBE INSERTER (K133921)Preceptis Medical2014-08-22
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM (K103595)Acclarent, Inc.2011-04-01
TYMPANOSTOMY TUBE (K082188)Acclarent, Inc.2008-09-19
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE (K071150)Heinz Kurz GmbH Medizintechnik2007-12-12
OTOMEDICS SOFT TYMPANOSTOMY TUBE (K071178)Otomedics Advanced Medical Technologies, Ltd.2007-06-22
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (K062672)Grace Medical, Inc.2006-10-24
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (K062385)Grace Medical, Inc.2006-09-27
NEOZOLINE VENTILATION TUBES (K061058)Adept Medical, Ltd.2006-07-12
MICRODOSE CATH, MODELS 90121-201, -202, -203 (K011383)Durect Corp.2001-06-25
PC COATED FLUOROPLASTIC VENT TUBES (K000801)Gyrus Ent LLC2000-06-19
FLUOROPLASTIC VENTILATION TUBES (K992222)Gyrus Ent LLC1999-08-26
SILVERSTEIN MICROWICK (K991670)Micromedics, Inc.1999-08-26
EXMOOR MYRINGOTOMY KIT (K980828)Exmoor Plastics , Ltd.1998-10-22
TYMPANOSTOMY TUBE (K981575)Grace Medical, Inc.1998-07-15
PFLEIDERER'S INTRATYMPANIC CATHETER (K974008)Exmoor Plastics , Ltd.1998-05-13
ROUND WINDOW E-CATH (K973740)Neuro-Biometrix, Inc.1998-03-23
SHAH PERMAVENT (K974007)Exmoor Plastics , Ltd.1997-12-12
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) (K973226)Heinz Kurz GmbH Medizintechnik1997-11-04
MYRINGOTOMY TUBE (K972126)Mednet Locator, Inc.1997-07-29
MYRINGOTOMY TUBE - BOBBIN WITH TAB (K972400)Mednet Locator, Inc.1997-07-23
MYRINGOTOMY TUBE (K971943)Mednet Locator, Inc.1997-07-23
TYMPANOSTOMY VENTILATION TUBE (K971454)Ikonos Corp.1997-05-29
TM MICRO-CATHETERS (K971124)Xomed, Inc.1997-05-16
ROUND WINDOW CATH (K965115)Neuro-Biometrix, Inc.1997-03-10
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER (K963727)Medtronic Xomed1997-02-11
ACTIVENT ANTIMICROBIAL VENTILATION TUBES (K961873)Xomed, Inc.1996-07-01
TYMPANOSTOMY VENTILATION TUBE (K961945)Advanced Microbotics Corp.1996-06-11
TYMPANOSTOMY VENTILATION TUBE (K960742)Advanced Microbotics Corp.1996-04-03
VENTILATION TUBES (K960477)Smith & Nephew, Inc.1996-02-26
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE (K955616)Misten Medical Corp.1996-01-17
TYMPANOSTOMY TUBE (K955447)Trebay Medical Corp.1995-12-21
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES (K954795)Trebay Medical Corp.1995-11-15
TYMPANOSTOMY TUBE (K953802)Bluff City Medical Technologies, Inc.1995-10-24
TYMPASNOSTOMY TUBE (K953993)Hampton Precision Products, Inc.1995-09-12
TYMPANOSTOMY (VENTILATION) TUBE (K941407)Xomed-Treace, Inc.1995-03-14
TYMPANOSTOMY TUBE (K943325)Grace Medical, Inc.1994-10-11
COLLAR BUTTON VENTURI VENT TUBE (K943848)Micromed Development Corp.1994-09-16
BOBBIN STYLE VENTURI VENT TUBE (K943847)Micromed Development Corp.1994-09-02
GROMMENT STYLE VENTURI TUBE (K943849)Micromed Development Corp.1994-09-02
POLYETHYLENE VENT TUBES (K943281)Micromed Development Corp.1994-08-24
C-FLEX VENT TUBES (K943190)Micromed Development Corp.1994-08-24
TYMPOVENT (K936275)Atos Medical AB1994-05-05
SILICONE TYMPANOSTOMY TUBES (K932166)Smith & Nephew Richards, Inc.1993-07-26
VENTILATION TUBES W/ HYDROGEL COATING (K923353)Microbio-Medics, Inc.1993-05-18
BEL-AIR VENTILATION TUBE (K926462)Exmoor Plastics , Ltd.1993-05-05
JACK'S VENT TUBES (K923887)O.R. Specialties, Inc.1993-02-19
TITANIUM VENTILATION TUBES (K921923)Exmoor Plastics , Ltd.1993-02-12
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES (K911580)Exmoor Plastics , Ltd.1991-09-24
SUH VENT TUBE (K910618)Boston Medical Products, Inc.1991-06-28
GROMMET STYLE VENTURI (K904597)River Medical, Inc.1991-01-28
COLLAR BUTTON STYLE VENTURI (K904594)River Medical, Inc.1991-01-28
BOBBIN STYLE VENTURI (K904592)River Medical, Inc.1991-01-28
MICRO BRIGHT VENTILATION TUBES (K903285)Invotec International, Inc.1990-09-26
JAHN VENTILATION TUBE (K900267)Smith & Nephew Richards, Inc.1990-06-14
PAPPAS TRI-FLANGE VENTILATION TUBE (K895242)Richards Medical Co., Inc.1989-11-17
DONALDSON VENTILATION TUBES PT. # AG/S9 (K883667)Exmoor Plastics , Ltd.1988-11-14
PUNCH MYRINGOTOMY SYSTEM (K882689)Xomed, Inc.1988-09-13
BIO-VENT REUTER BOBBIN TUBE (K870877)Richards Medical Co., Inc.1987-03-26
'EXMOOR' T-TUBE (K871035)Exmoor Plastics , Ltd.1987-03-23
VENTILATION TUBES WITH HYDROGEL COATING (K870129)Richards Medical Co., Inc.1987-02-10
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE (K852387)Xomed, Inc.1986-01-06
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE (K853641)Xomed, Inc.1986-01-06
TYMPANOSTOMY TUBES-VARIOUS (K833246)Abco Dealers, Inc.1985-01-04
UNIFLOW VENT TUBE (K842637)Richards Medical Co., Inc.1984-10-25
DONALDSON VENT TUBE (K823910)Treace Medical, Inc.1983-11-22
TSH RIA (K833910)Syncor Intl. Corp.1983-11-22
VENTRESCREEN BETA-HCG ENZYME IMMUNO (K833909)Vxr, Inc.1983-11-21
DONALDSON-TYPE VENT TUBE (K832362)Concept, Inc.1983-10-14
CONCEPT T-TUBE (K832361)Concept, Inc.1983-10-14
SOILEAU TYTAN BOBBIN VENT TUBE (K830584)Treace Medical, Inc.1983-06-02
T-TUBE VENT TUBE (K823909)Treace Medical, Inc.1983-03-17
OTOLOGICAL VENTILATION TUBES-VARIOUS (K830228)Micromedics, Inc.1983-03-07
COLLAR BUTTON VENT TUBE (K823907)Treace Medical, Inc.1983-01-28
GROMMET VENT TUBE (K823908)Treace Medical, Inc.1983-01-28
COLLAR BUTTON VENT TUBE (K830085)Treace Medical, Inc.1983-01-28
TYMPANOSTOMY TUBES & VARIOUS TYPES (K822017)Kelleher Corp.1982-10-27
TYTAN REUTER BOBBIN VENT TUBE (K822376)Treace Medical, Inc.1982-09-09
ARMSTRONG V VENT TUBE (K822375)Treace Medical, Inc.1982-09-09
TYTAN GROMMET VENT TUBE, .040 (K822366)Treace Medical, Inc.1982-09-02
TYMPANOSTOMY TUBES (VARIOUS MODELS (K820510)Abco Dist.1982-03-19
REUTER BOBBIN VENTILA. TUBE-TITANIUM (K820362)Richard'S Medical Equip., Inc.1982-03-02
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT (K813616)Humboldt Products1982-01-22
EXMOOR AURAL GROMMET AG/TI (K812459)Exmoor Plastics , Ltd.1981-09-25
VARIOUS AURAL GROMMETS (K812460)Exmoor Plastics , Ltd.1981-09-21
CARL ZEISS INN MYRINGOTOMY TUBE LINE (K811698)James L. Geraci & Associates, Inc.1981-08-31
EXMOOR AURAL GROMMET AG/T4 (K810705)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET (K810701)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T3 (K810704)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T2L (K810702)Exmoor Plastics , Ltd.1981-04-14
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