Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Acclarent, Inc. — Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
262 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026-02-19 | 93 | 0 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | 2023-12-13 | 271 | 0 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023-07-21 | 28 | 1 |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 | 104 | 0 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 | 122 | 0 |
| K201174 | TruDi Curette | Acclarent, Inc. | 2020-08-12 | 103 | 0 |
| K193453 | TruDi Probe | Acclarent, Inc. | 2020-03-23 | 101 | 0 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 | 60 | 0 |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019-05-03 | 60 | 0 |
| K183090 | Relieva Tract Balloon Dilation System | Acclarent, Inc. | 2019-04-19 | 164 | 0 |
| K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018-07-20 | 100 | 1 |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018-03-10 | 106 | 0 |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018-01-16 | 216 | 0 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 | 90 | 0 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 | 126 | 0 |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016-10-24 | 126 | 0 |
| DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2016-09-16 | 284 | 0 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 | 85 | 0 |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015-05-20 | 89 | 0 |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015-04-22 | 128 | 0 |
| K150172 | ACCLARENT SE Inflation Device | Acclarent, Inc. | 2015-04-07 | 71 | 0 |
| K132433 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2014-04-24 | 262 | 0 |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Acclarent, Inc. | 2014-02-20 | 29 | 0 |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | Acclarent, Inc. | 2012-11-05 | 280 | 0 |
| K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | Acclarent, Inc. | 2011-10-11 | 102 | 0 |
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | 2011-10-07 | 210 | 0 |
| K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | Acclarent, Inc. | 2011-08-22 | 110 | 0 |
| K110636 | TULA IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2011-06-16 | 104 | 0 |
| K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2011-05-27 | 134 | 0 |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY S | Acclarent, Inc. | 2011-04-01 | 114 | 0 |
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | Acclarent, Inc. | 2011-03-31 | 65 | 9 |
| K100577 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2011-01-06 | 311 | 0 |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2010-03-03 | 104 | 0 |
| K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | Acclarent, Inc. | 2009-06-12 | 92 | 7 |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2009-01-29 | 57 | 0 |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | 2008-09-19 | 46 | 0 |
| K072891 | SINUS SPACER | Acclarent, Inc. | 2008-03-19 | 161 | 0 |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | Acclarent, Inc. | 2008-03-11 | 134 | 0 |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2008-03-05 | 105 | 0 |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | 2007-09-28 | 85 | 0 |
| K063078 | MICROENDOSCOPE | Acclarent, Inc. | 2006-10-24 | 14 | 0 |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | 2006-09-15 | 23 | 0 |
| K061903 | RELIEVA SINUS BALLOON CATHETER | Acclarent, Inc. | 2006-08-18 | 44 | 0 |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | 2006-05-05 | 25 | 0 |
| K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | Acclarent, Inc. | 2005-08-31 | 19 | 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