Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
West Pharma. Services IL, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
302 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | 2024-01-19 | 280 | 0 |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2023-12-14 | 90 | 0 |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023-12-01 | 239 | 0 |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | 2023-05-22 | 90 | 0 |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022-08-31 | 302 | 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