Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sinclair Pharmaceuticals, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
624 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050158 | SINCLAIR SEBORRHEA EMULSION | Sinclair Pharmaceuticals, Ltd. | 2006-10-11 | 624 | 0 |
| K042722 | ALOCLAIR ORAL SPRAY | Sinclair Pharmaceuticals, Ltd. | 2005-01-13 | 104 | 0 |
| K040950 | ALOCLAIR ORAL GEL | Sinclair Pharmaceuticals, Ltd. | 2004-06-21 | 70 | 0 |
| K024148 | SALINUM, ORCLAIR | Sinclair Pharmaceuticals, Ltd. | 2003-09-15 | 273 | 0 |
| K024367 | SINCLAIR WOUND AND SKIN EMULSION | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 | 209 | 0 |
| K023046 | SST SALIVA SUPPORTING TABLETS | Sinclair Pharmaceuticals, Ltd. | 2002-12-02 | 81 | 0 |
| K023155 | ALOCLAIR ORAL RINSE | Sinclair Pharmaceuticals, Ltd. | 2002-11-25 | 63 | 0 |
| K013056 | GELCLAIR CONCENTRATED ORAL GEL | Sinclair Pharmaceuticals, Ltd. | 2001-12-21 | 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