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FDA 510(k)

freeflex+ Transfer Adapter

K-Number: K212445 · 2022-06-01

ApplicantFresenius Kabi AG
Decision Date2022-06-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

freeflex+ Transfer Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K212445. 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 freeflex+ Transfer Adapter?

freeflex+ Transfer Adapter is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is Fresenius Kabi AG. The 510(k) number is K212445.

When did freeflex+ Transfer Adapter receive FDA 510(k) clearance?

freeflex+ Transfer Adapter received FDA 510(k) clearance on 2022-06-01, under 510(k) number K212445.

Who is the listed applicant for freeflex+ Transfer Adapter?

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

What is the FDA product code for freeflex+ Transfer Adapter?

The FDA product code for freeflex+ Transfer Adapter is LHI.

Other records listing Fresenius Kabi AG as applicant

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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.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® 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 Pharmaceuticals

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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