Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avantis Medical Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
255 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | Avantis Medical Systems, Inc. | 2016-05-17 | 99 | 0 |
| K140595 | THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2014-11-17 | 255 | 0 |
| K093187 | MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYS | Avantis Medical Systems, Inc. | 2009-11-05 | 27 | 0 |
| K091783 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM | Avantis Medical Systems, Inc. | 2009-07-07 | 20 | 0 |
| K083180 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2009-02-12 | 107 | 0 |
| K070330 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2007-04-24 | 78 | 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