Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medivators (A Subsidiary of Steris Corporation) · 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) |
|---|---|---|---|---|---|
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 | 255 | 0 |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Singl | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 | 244 | 0 |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifi | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 | 140 | 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