Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Luminex Corporation — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
203 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation2026-05-191760
K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation2025-06-062060
K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation2025-04-182030
K240627LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation2024-06-04900
K233410LIAISON PLEX Respiratory Flex AssayLuminex Corporation2024-03-011470
K191742ARIES MRSA AssayLuminex Corporation2019-09-25860
K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay ProtocoLuminex Corporation2017-10-30821
K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile AsLuminex Corporation2017-07-21661
K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol FileLuminex Corporation2017-05-021311
K162772ARIES GBS AssayLuminex Corporation2016-12-23812
K161220ARIES® Flu A/B & RSV AssayLuminex Corporation2016-08-02951
K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 Luminex Corporation2016-06-30292
K160517ARIES SystemLuminex Corporation2016-04-12482
K151917ARIES SystemLuminex Corporation2015-10-06851
K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSLuminex Corporation2015-10-06851

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