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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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972946AURELUX 77Aurex Precious Metal Industries (Pty)Ltd1997-12-191820
K972945AURENORM 68Aurex Precious Metal Industries (Pty)Ltd1997-11-261590
K972949AURELUX BIO Y85PFAurex Precious Metal Industries (Pty)Ltd1997-09-18900
K972943AURECAST 92Aurex Precious Metal Industries (Pty)Ltd1997-09-16880
K972950HIPALLAUR 19Aurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972951HIPALLAUR 51Aurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972952AUREBOND 51Aurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972953PALAUREX 76KFAurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972954PALAUREX 78Aurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972955PALCERAM 56Aurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972956PALCERAM 82SFAurex Precious Metal Industries (Pty)Ltd1997-09-05770
K972941AURECAST 74Aurex Precious Metal Industries (Pty)Ltd1997-08-28690
K972942AURECAST 83Aurex Precious Metal Industries (Pty)Ltd1997-08-28690
K972319AURECAST GFAurex Precious Metal Industries (Pty)Ltd1997-08-26670
K972939AURECAST BIO 59PFAurex Precious Metal Industries (Pty)Ltd1997-08-26670
K972940AURECAST BIO 69PFAurex Precious Metal Industries (Pty)Ltd1997-08-26670
K972936AURECAST 2Aurex Precious Metal Industries (Pty)Ltd1997-08-25660
K972937AURECAST 4Aurex Precious Metal Industries (Pty)Ltd1997-08-25660
K972938AURECAST 10Aurex Precious Metal Industries (Pty)Ltd1997-08-25660

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