Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Crosstex International, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX | Crosstex International, Inc. | 2011-10-06 | 146 | 0 |
| K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EAR | Crosstex International, Inc. | 2010-12-23 | 44 | 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