Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Entellus Medical, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
139 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220027 | Audion ET dilation system | Entellus Medical, Inc. | 2022-04-12 | 97 | 0 |
| K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017-04-05 | 111 | 0 |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Entellus Medical, Inc. | 2017-04-05 | 119 | 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 |
| 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 |
| K133563 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2013-12-20 | 30 | 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 |
| 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 |
| K111763 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | 2011-09-15 | 84 | 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 |
| K102366 | FINESS ENDOSCOPE | Entellus Medical, Inc. | 2011-02-15 | 179 | 0 |
| K103213 | FINESS ENDOSCOPE STERILIZATION TRAY | Entellus Medical, Inc. | 2011-02-02 | 93 | 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 |
| K082569 | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE | Entellus Medical, Inc. | 2008-09-18 | 13 | 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 |
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