Cleared Traditional

HyHub? and HyHub? Duo Vial Access Devices

K243404 · Takeda Pharmaceuticals · General Hospital

Jul 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K243404 is an FDA 510(k) clearance for the HyHub? and HyHub? Duo Vial Access Devices, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Takeda Pharmaceuticals (Cambridge, US). The FDA issued a Cleared decision on July 18, 2025, 259 days after receiving the submission on November 1, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K243404 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2024
Decision Date	July 18, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF