Vial Adapter 20mm— 510(k) K232875

Name: FDA 510(k) clearance K232875
Creator: U.S. Food and Drug Administration
Published: 2023-12-14

Substantially Equivalent

West Pharma. Services IL, Ltd.

FDA 510(k) clearance K232875 for Vial Adapter 20mm, Substantially Equivalent on 2023-12-14. Applicant: West Pharma. Services IL, Ltd.. Device class: 2.

Clearance details

Applicant: West Pharma. Services IL, Ltd.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2023-09-15
Decision date: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana Central, IL

Download summary PDF View on FDA.gov ↗

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K260301 — Vial Adapter2026-06-05
K250345 — Medline Bag Decanter2025-10-24
K251715 — FlowArt® Vial Access Device Vented2025-10-14
K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more2025-09-16

More clearances from West Pharma. Services IL, Ltd.

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K231071 — Mix2Vial® Transfer Device2024-01-19
K230988 — Vial2Bag Advanced® 13mm Admixture Device2023-12-01
K230464 — MixJect® Transfer Device2023-05-22
K213513 — Vented Vial Adapter 20mm2022-08-31

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.