Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Majestic Drug Co., Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101771 | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. | 2010-09-20 | 88 | 0 |
| K964773 | DENTEMP ONE STEP | Majestic Drug Co., Inc. | 1997-02-21 | 86 | 2 |
| K821581 | DEN TEMP | Majestic Drug Co., Inc. | 1982-06-14 | 17 | 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