FDA applicant
West Pharma. Services IL, Ltd.
FDA records 5 decisions for West Pharma. Services IL, Ltd. (Ra'Anana Central, IL) from 2022 to 2024: 5 510(k) clearances. All are in product code LHI (Set, I.V. Fluid Transfer). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided West Pharma. Services IL, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like West Pharma. Services IL, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report