Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hathor Professional Skincare , Ltd. · 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) |
|---|---|---|---|---|---|
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147 | Hathor Professional Skincare , Ltd. | 2026-06-09 | 270 | 0 |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. | 2025-05-02 | 60 | 0 |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011 | Hathor Professional Skincare , Ltd. | 2025-01-21 | 244 | 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