Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
West Pharmaceutical Services, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
206 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 | 28 | 0 |
| K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | 2017-02-02 | 49 | 0 |
| K151777 | Intradermal Adapter | West Pharmaceutical Services, Inc. | 2015-09-29 | 90 | 0 |
| K123588 | INTRADERMAL ADAPTER | West Pharmaceutical Services, Inc. | 2013-02-19 | 90 | 0 |
| K082908 | NOVAGUARD, MODEL 3611001 | West Pharmaceutical Services, Inc. | 2009-04-24 | 206 | 0 |
| K041691 | CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT | West Pharmaceutical Services, Inc. | 2004-08-05 | 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