Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HyHub™ and HyHub™ Duo Vial Access Devices

K-Number: K243404 · 2025-07-18

ApplicantTakeda Pharmaceuticals
Decision Date2025-07-18
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HyHub™ and HyHub™ Duo Vial Access Devices is the device name listed in this FDA 510(k) record. The listed applicant is Takeda Pharmaceuticals. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K243404. 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 HyHub™ and HyHub™ Duo Vial Access Devices?

HyHub™ and HyHub™ Duo Vial Access Devices is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Takeda Pharmaceuticals. The 510(k) number is K243404.

When did HyHub™ and HyHub™ Duo Vial Access Devices receive FDA 510(k) clearance?

HyHub™ and HyHub™ Duo Vial Access Devices received FDA 510(k) clearance on 2025-07-18, under 510(k) number K243404.

Who is the listed applicant for HyHub™ and HyHub™ Duo Vial Access Devices?

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

What is the FDA product code for HyHub™ and HyHub™ Duo Vial Access Devices?

The FDA product code for HyHub™ and HyHub™ Duo Vial Access Devices 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, 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, LLCK240761Arisure® 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.

↑