Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genoss — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151731 | Rainbow Paste Stain | Genoss | 2016-04-15 | 294 | 0 |
| K151842 | Rainbow Shine | Genoss | 2016-01-14 | 191 | 0 |
| K151846 | Rainbow LS Pressing | Genoss | 2016-01-14 | 191 | 0 |
| K151723 | Rainbow Trans | Genoss | 2015-10-28 | 124 | 0 |
| K151844 | Rainbow Shade | Genoss | 2015-10-16 | 101 | 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