Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aurex SA (Pty) , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
43 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001481 | PALCERAM 49 | Aurex SA (Pty) , Ltd. | 2000-06-23 | 43 | 0 |
| K001482 | AURENORM 75 KF | Aurex SA (Pty) , Ltd. | 2000-06-23 | 43 | 0 |
| K001480 | AURECAST 40 B | Aurex SA (Pty) , Ltd. | 2000-06-21 | 41 | 0 |
| K001479 | PALCERAM 53 | Aurex SA (Pty) , Ltd. | 2000-06-21 | 41 | 0 |
| K001477 | AURELUX Y 84 PREMIUM | Aurex SA (Pty) , Ltd. | 2000-06-20 | 40 | 0 |
| K001478 | AURECAST SUPER INLAY | Aurex SA (Pty) , Ltd. | 2000-06-20 | 40 | 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