Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Metalor Technologies USA — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020062 | XERAFIT | Metalor Technologies USA | 2002-02-14 | 37 | 0 |
| K013769 | V-GNATHOS SUPRA | Metalor Technologies USA | 2002-01-22 | 70 | 0 |
| K013506 | YELLOW SPECIAL | Metalor Technologies USA | 2002-01-03 | 73 | 0 |
| K013505 | AUROFLUID PLUS | Metalor Technologies USA | 2001-12-19 | 58 | 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