K243404 is an FDA 510(k) clearance for the HyHub™ and HyHub™ Duo Vial Access Devices. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K243404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |