Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Veratex 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) |
|---|---|---|---|---|---|
| K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Veratex Corp. | 1983-02-18 | 31 | 0 |
| K801032 | STERILE DRAPE 17X18 CODE D-6A | Veratex Corp. | 1980-05-20 | 19 | 0 |
| K801033 | STERILE DRAPE 17X18 W/3 FENESTRATION | Veratex Corp. | 1980-05-20 | 19 | 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