Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genicon, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
126 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190168 | Aquas Probes | Genicon, Inc. | 2019-03-14 | 42 | 0 |
| K181791 | SIMPLYSTRONG, SIMPLYEZEE | Genicon, Inc. | 2018-08-21 | 47 | 0 |
| K180836 | Genistrong | Genicon, Inc. | 2018-04-18 | 19 | 0 |
| K180579 | Ezee Retrieval | Genicon, Inc. | 2018-03-19 | 14 | 0 |
| K171752 | X-SURGE | Genicon, Inc. | 2017-10-17 | 126 | 0 |
| K162059 | EZEE RETRIEVAL | Genicon, Inc. | 2016-09-29 | 65 | 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