West Pharma. Services IL, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “West Pharma. Services IL, Ltd.” (first 2022, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 239 days. Since 2017 the median was 239 days, against 199 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 302 |
| 2023 | 3 | 90 |
| 2024 | 1 | 280 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name West Pharma. Services IL, Ltd. took a median 239 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 5 | 5 |
Review panels
- General Hospital (5)
Most recent West Pharma. Services IL, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231071 | Mix2Vial® Transfer Device | LHI | 2024-01-19 | 280 |
| K232875 | Vial Adapter 20mm | LHI | 2023-12-14 | 90 |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | LHI | 2023-12-01 | 239 |
| K230464 | MixJect® Transfer Device | LHI | 2023-05-22 | 90 |
| K213513 | Vented Vial Adapter 20mm | LHI | 2022-08-31 | 302 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-12-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- West Pharmaceutical Services, Inc. (7 510(k)s)
- West Chester Marketing, Inc. (1 510(k)s)
- West Coast Optical Instruments, Inc. (1 510(k)s)
- West Lake Marketing (1 510(k)s)
- West Pharmaceutical Services Az, Inc. (1 510(k)s)
- West Texas Lighthouse For the Blind (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under West Pharma. Services IL, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “West Pharma. Services IL, Ltd.” (first 2022, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by West Pharma. Services IL, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name West Pharma. Services IL, Ltd. is 239 days. Since 2017: 239 days, versus 199 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under West Pharma. Services IL, Ltd.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 5).
Next steps
- See all 5 West Pharma. Services IL, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LHI, West Pharma. Services IL, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.