Vented Vial Adapter 20mm

FDA 510(k) K213513 · West Pharma. Services IL, Ltd.

Substantially Equivalent

510(k) numberK213513

Submission

Device name
Vented Vial Adapter 20mm
Applicant
West Pharma. Services IL, Ltd.
Ra'Anana Central, IL
Received
November 2, 2021
Decision date
August 31, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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K240761Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional Yukon Medical, LLC03/21/2025SE
K243985Rio™ Drug Reconstitution Transfer DeviceLHI · Traditional Icu Medical, Inc.01/22/2025SE
K243486SmartSiteTM Vented Vial Access DeviceLHI · Traditional Yukon Medical, LLC12/06/2024SE
K241976nextaro® va, 15mm, 5µmLHI · Special Sfm Medical Devices GmbH09/06/2024SE

More from Sfm Medical Devices GmbH

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Questions and answers

When was Vented Vial Adapter 20mm cleared by the FDA?

Vented Vial Adapter 20mm (K213513) received a 510(k) decision of Substantially Equivalent on August 31, 2022, 302 days after the submission was received.

What is the product code of K213513?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.