Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qualis, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
147 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050212 | PERSONAL WARMING JELLY | Qualis, Inc. | 2005-03-17 | 45 | 0 |
| K050211 | PERSONAL WARMING GEL | Qualis, Inc. | 2005-03-17 | 45 | 0 |
| K041129 | PERSONAL LUBRICATING GEL | Qualis, Inc. | 2004-09-24 | 147 | 0 |
| K040085 | PERSONAL WARMING LUBRICANT | Qualis, Inc. | 2004-04-20 | 95 | 0 |
| K973780 | PERSONAL LUBRICATING LIQUID | Qualis, Inc. | 1997-11-26 | 54 | 0 |
| K973557 | LUBRIGLIDE | Qualis, Inc. | 1997-10-10 | 21 | 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