510(k) Report

FDA applicant

West Pharmaceutical Services Az, Inc.

Scottsdale, AZ1 decision2020–20201 recall

FDA records 1 decision for West Pharmaceutical Services Az, Inc. (Scottsdale, AZ) in 2020: 1 510(k) clearance. All are in product code LHI (Set, I.V. Fluid Transfer). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 Az, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2020high 1 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — West Pharmaceutical Services Az, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like West Pharmaceutical Services Az, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LHISet, I.V. Fluid Transfer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 20204cite it

What has FDA decided for it lately?

  • K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 20201 recall

The one decision as West Pharmaceutical Services Az, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K201415Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device…Sep 24, 2024Class II