Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRC — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
163 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 | 114 | 0 |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 | 156 | 0 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 | 140 | 0 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 | 122 | 0 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 | 84 | 0 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 | 570 | 0 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 | 60 | 0 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 | 163 | 0 |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 | 92 | 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 |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 | 100 | 0 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 | 85 | 0 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 | 124 | 0 |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 | 85 | 0 |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015-11-20 | 85 | 0 |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | 2015-08-27 | 240 | 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 |
| K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014-10-17 | 64 | 0 |
| K141916 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2014-08-07 | 23 | 0 |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Acclarent, Inc. | 2014-02-20 | 29 | 0 |
| K133563 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2013-12-20 | 30 | 0 |
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | Helix Medical, LLC | 2013-12-17 | 274 | 0 |
| K133016 | VENT-OS SINUS DILATION SYSTEM | Sinusys Corporation | 2013-12-09 | 75 | 0 |
| K132297 | EM SINUS DILATION SYSTEM | Medtronic Xomed, Inc. | 2013-11-05 | 104 | 0 |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | Arthrocare Corp. | 2013-10-04 | 115 | 0 |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2013-10-04 | 59 | 0 |
| K130503 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2013-06-11 | 104 | 0 |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | Acclarent, Inc. | 2012-11-05 | 280 | 0 |
| K121351 | SINUS DILATION SYSTEM | Entrigue Surgical, Inc. | 2012-08-29 | 117 | 0 |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2012-08-22 | 50 | 0 |
| K121174 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2012-05-17 | 30 | 0 |
| K120962 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | 2012-04-27 | 28 | 0 |
| K120735 | PATHASSIT LIGHT SEEKER | Entellus Medical, Inc. | 2012-04-02 | 24 | 0 |
| K113522 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2012-01-27 | 59 | 0 |
| K112506 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2011-12-21 | 113 | 0 |
| K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | Acclarent, Inc. | 2011-10-11 | 102 | 0 |
| K111763 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | 2011-09-15 | 84 | 0 |
| K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | Acclarent, Inc. | 2011-08-22 | 110 | 0 |
| K110739 | ENTELLUS MEDICAL SINUS GUIDEWIRE | Entellus Medical, Inc. | 2011-06-14 | 89 | 0 |
| K110158 | ILLUMINATING SINUS SEEKER | Entellus Medical, Inc. | 2011-06-07 | 139 | 0 |
| K102003 | XPRESS BALLOON DEVICE | Entellus Medical, Inc. | 2010-10-22 | 99 | 0 |
| K093007 | ENTELLUS MEDICAL BALLOON DEVICE | Entellus Medical, Inc. | 2010-02-05 | 130 | 0 |
| K091681 | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) | Entellus Medical, Inc. | 2009-07-08 | 28 | 0 |
| K081542 | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | 2008-06-27 | 25 | 0 |
| K072302 | ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | 2008-04-08 | 235 | 0 |
| K061903 | RELIEVA SINUS BALLOON CATHETER | Acclarent, Inc. | 2006-08-18 | 44 | 0 |
| K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | Acclarent, Inc. | 2005-08-31 | 19 | 0 |
| K043527 | RELIEVA SINUS BALLOON DILATION CATHETER | Exploramed Nc1, Inc. | 2005-04-05 | 105 | 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