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FDA 510(k)

FlowArt® Vial Access Device Vented

K-Number: K251715 · 2025-10-14

ApplicantAsset Medikal
Decision Date2025-10-14
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FlowArt® Vial Access Device Vented is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K251715. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowArt® Vial Access Device Vented?

FlowArt® Vial Access Device Vented is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Asset Medikal. The 510(k) number is K251715.

When did FlowArt® Vial Access Device Vented receive FDA 510(k) clearance?

FlowArt® Vial Access Device Vented received FDA 510(k) clearance on 2025-10-14, under 510(k) number K251715.

Who is the listed applicant for FlowArt® Vial Access Device Vented?

The FDA 510(k) record lists Asset Medikal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlowArt® Vial Access Device Vented?

The FDA product code for FlowArt® Vial Access Device Vented is LHI.

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda PharmaceuticalsK240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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