Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ETD — Predicate Candidate Screening
116 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
215 days90th percentile
116clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026-04-23 | 265 | 0 |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo | Aventamed Dac | 2025-04-28 | 90 | 0 |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024-05-20 | 258 | 0 |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024-02-16 | 93 | 0 |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023-11-24 | 136 | 0 |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022-07-27 | 86 | 0 |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020-06-05 | 57 | 0 |
| K171239 | TULA Tube Delivery System | Tusker Medical | 2017-06-28 | 62 | 0 |
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | 2015-09-21 | 77 | 0 |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015-07-22 | 92 | 0 |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | 2015-04-23 | 251 | 0 |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | 2014-08-22 | 242 | 0 |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY S | Acclarent, Inc. | 2011-04-01 | 114 | 0 |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | 2008-09-19 | 46 | 0 |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODE | Heinz Kurz GmbH Medizintechnik | 2007-12-12 | 231 | 0 |
| K071178 | OTOMEDICS SOFT TYMPANOSTOMY TUBE | Otomedics Advanced Medical Technologies, Ltd. | 2007-06-22 | 56 | 0 |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | Grace Medical, Inc. | 2006-10-24 | 46 | 0 |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | Grace Medical, Inc. | 2006-09-27 | 43 | 0 |
| K061058 | NEOZOLINE VENTILATION TUBES | Adept Medical, Ltd. | 2006-07-12 | 86 | 7 |
| K011383 | MICRODOSE CATH, MODELS 90121-201, -202, -203 | Durect Corp. | 2001-06-25 | 49 | 0 |
| K000801 | PC COATED FLUOROPLASTIC VENT TUBES | Gyrus Ent LLC | 2000-06-19 | 98 | 0 |
| K992222 | FLUOROPLASTIC VENTILATION TUBES | Gyrus Ent LLC | 1999-08-26 | 56 | 0 |
| K991670 | SILVERSTEIN MICROWICK | Micromedics, Inc. | 1999-08-26 | 101 | 0 |
| K980828 | EXMOOR MYRINGOTOMY KIT | Exmoor Plastics , Ltd. | 1998-10-22 | 233 | 0 |
| K981575 | TYMPANOSTOMY TUBE | Grace Medical, Inc. | 1998-07-15 | 72 | 0 |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | Exmoor Plastics , Ltd. | 1998-05-13 | 208 | 0 |
| K973740 | ROUND WINDOW E-CATH | Neuro-Biometrix, Inc. | 1998-03-23 | 173 | 0 |
| K974007 | SHAH PERMAVENT | Exmoor Plastics , Ltd. | 1997-12-12 | 52 | 0 |
| K973226 | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUB | Heinz Kurz GmbH Medizintechnik | 1997-11-04 | 69 | 0 |
| K972126 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-29 | 54 | 0 |
| K972400 | MYRINGOTOMY TUBE - BOBBIN WITH TAB | Mednet Locator, Inc. | 1997-07-23 | 48 | 0 |
| K971943 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-23 | 57 | 0 |
| K971454 | TYMPANOSTOMY VENTILATION TUBE | Ikonos Corp. | 1997-05-29 | 38 | 0 |
| K971124 | TM MICRO-CATHETERS | Xomed, Inc. | 1997-05-16 | 50 | 0 |
| K965115 | ROUND WINDOW CATH | Neuro-Biometrix, Inc. | 1997-03-10 | 80 | 0 |
| K963727 | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER | Medtronic Xomed | 1997-02-11 | 148 | 0 |
| K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | Xomed, Inc. | 1996-07-01 | 47 | 0 |
| K961945 | TYMPANOSTOMY VENTILATION TUBE | Advanced Microbotics Corp. | 1996-06-11 | 22 | 0 |
| K960742 | TYMPANOSTOMY VENTILATION TUBE | Advanced Microbotics Corp. | 1996-04-03 | 40 | 0 |
| K960477 | VENTILATION TUBES | Smith & Nephew, Inc. | 1996-02-26 | 25 | 0 |
| K955616 | MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE | Misten Medical Corp. | 1996-01-17 | 37 | 0 |
| K955447 | TYMPANOSTOMY TUBE | Trebay Medical Corp. | 1995-12-21 | 22 | 0 |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | Trebay Medical Corp. | 1995-11-15 | 28 | 0 |
| K953802 | TYMPANOSTOMY TUBE | Bluff City Medical Technologies, Inc. | 1995-10-24 | 78 | 0 |
| K953993 | TYMPASNOSTOMY TUBE | Hampton Precision Products, Inc. | 1995-09-12 | 19 | 0 |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | Xomed-Treace, Inc. | 1995-03-14 | 356 | 0 |
| K943325 | TYMPANOSTOMY TUBE | Grace Medical, Inc. | 1994-10-11 | 92 | 0 |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Micromed Development Corp. | 1994-09-16 | 43 | 0 |
| K943847 | BOBBIN STYLE VENTURI VENT TUBE | Micromed Development Corp. | 1994-09-02 | 29 | 0 |
| K943849 | GROMMENT STYLE VENTURI TUBE | Micromed Development Corp. | 1994-09-02 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda