Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blairex Laboratories, Inc. — 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) |
|---|---|---|---|---|---|
| K083355 | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 9 | Blairex Laboratories, Inc. | 2008-12-29 | 46 | 0 |
| K833903 | BENZETHONIUM CHLORIDE | Blairex Laboratories, Inc. | 1984-05-30 | 198 | 0 |
| K832810 | HARD CONTACT LENS CLEANER | Blairex Laboratories, Inc. | 1983-09-29 | 42 | 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