510(k) Report

FDA applicant

West Pharmaceutical Services, Inc.

Exton, PA7 decisions2004–20240 recalls

FDA records 7 decisions for West Pharmaceutical Services, Inc. (Exton, PA) from 2004 to 2024: 7 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMF (Syringe, Piston). Its devices cite 13 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “West Pharmaceutical Services”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided West Pharmaceutical Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12013: 12014: 12015: 12017: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — West Pharmaceutical Services, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like West Pharmaceutical Services, Inc.’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

Which product codes does it file in?

  • MEGSyringe, Antistick2decisions
  • FMFSyringe, Piston2decisions
  • LHISet, I.V. Fluid Transfer2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123588Intradermal AdapterWest Pharmaceutical Services, Inc. · 20132cite it
  • K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 20042cite it
  • K141464Novaguard S a Safety SystemWest Pharmaceutical Services · 20141cites it

What has FDA decided for it lately?

  • K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024
  • K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. · 2017
  • K151777Intradermal AdapterWest Pharmaceutical Services, Inc. · 2015
  • K141464Novaguard S a Safety SystemWest Pharmaceutical Services · 2014
  • K123588Intradermal AdapterWest Pharmaceutical Services, Inc. · 2013
  • K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009
  • K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004

All 6 as West Pharmaceutical Services, Inc. →The one decision as West Pharmaceutical Services →