FDA 510(k)

HyHub and HyHub Duo Vial Access Devices

K-Number: K243404 · 2025-07-18

Decision Date2025-07-18

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HyHub and HyHub Duo Vial Access Devices is a medical device manufactured by Takeda Pharmaceuticals. It received FDA 510(k) clearance on 2025-07-18 under approval 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. It is manufactured by Takeda Pharmaceuticals. The 510(k) number is K243404.

When was HyHub and HyHub Duo Vial Access Devices approved by the FDA?

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

What company makes HyHub and HyHub Duo Vial Access Devices?

HyHub and HyHub Duo Vial Access Devices is manufactured by Takeda Pharmaceuticals.

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.

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41768269 Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes. Frontiers in medical technology (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41613088 Orphan medical devices: addressing the regulatory and access gaps in the EU and US. Frontiers in public health (2025)

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Official Source

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