Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aurex Precious Metal Industries (Pty)Ltd · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
159 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972946 | AURELUX 77 | Aurex Precious Metal Industries (Pty)Ltd | 1997-12-19 | 182 | 0 |
| K972945 | AURENORM 68 | Aurex Precious Metal Industries (Pty)Ltd | 1997-11-26 | 159 | 0 |
| K972949 | AURELUX BIO Y85PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-18 | 90 | 0 |
| K972943 | AURECAST 92 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-16 | 88 | 0 |
| K972950 | HIPALLAUR 19 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972951 | HIPALLAUR 51 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972952 | AUREBOND 51 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972953 | PALAUREX 76KF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972954 | PALAUREX 78 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972955 | PALCERAM 56 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972956 | PALCERAM 82SF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | 77 | 0 |
| K972941 | AURECAST 74 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 | 69 | 0 |
| K972942 | AURECAST 83 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 | 69 | 0 |
| K972319 | AURECAST GF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | 67 | 0 |
| K972939 | AURECAST BIO 59PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | 67 | 0 |
| K972940 | AURECAST BIO 69PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | 67 | 0 |
| K972936 | AURECAST 2 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | 66 | 0 |
| K972937 | AURECAST 4 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | 66 | 0 |
| K972938 | AURECAST 10 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | 66 | 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