Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Luminex Corp. — 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) |
|---|---|---|---|---|---|
| K133302 | FLEXMAP 3D | Luminex Corp. | 2014-01-10 | 77 | 0 |
| K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SP | Luminex Corp. | 2013-01-09 | 245 | 0 |
| K073506 | LUMINEX LX 100/200 INSTRUMENT | Luminex Corp. | 2008-03-07 | 85 | 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