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FDA 510(k)

Medline Bag Decanter

K-Number: K250345 · 2025-10-24

ApplicantMedline Industries, LP
Decision Date2025-10-24
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medline Bag Decanter is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K250345. 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 Medline Bag Decanter?

Medline Bag Decanter is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Medline Industries, LP. The 510(k) number is K250345.

When did Medline Bag Decanter receive FDA 510(k) clearance?

Medline Bag Decanter received FDA 510(k) clearance on 2025-10-24, under 510(k) number K250345.

Who is the listed applicant for Medline Bag Decanter?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Bag Decanter?

The FDA product code for Medline Bag Decanter is LHI.

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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.K251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline 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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