Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Crosstex International · 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) |
|---|---|---|---|---|---|
| K140566 | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICAT | Crosstex International | 2014-11-24 | 264 | 0 |
| K140620 | SPORVIEW PLUS BI TEST PACK | Crosstex International | 2014-08-07 | 149 | 0 |
| K133204 | AIRVIEW MINI OWIE DICK TEST PACK | Crosstex International | 2014-05-05 | 200 | 0 |
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUI | Crosstex International | 2008-10-16 | 69 | 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