Takeda Pharmaceuticals · Class II · Cleared Jul 18, 2025
| K-number | K243404 |
| Device name | HyHub and HyHub Duo Vial Access Devices |
| Applicant | Takeda Pharmaceuticals |
| Product code | LHI |
| Device class | Class II |
| Decision date | Jul 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5440 |
The HyHub™ and HyHub™ Duo Vial Access Devices are single-use, disposable, needle-free vial access devices designed to allow transfer of drugs from vials without needles in home and clinical settings. The devices accommodate 2 or 4 dual vial units and enable sequential, needleless withdrawal of medicinal liquids using standard syringe, pump, and infusion set connections for patients 17 years and older.
Both the subject and predicate devices feature spikes to pierce vials, multiple spikes connected in series with flexible PVC tubing, hydrophobic air filters for venting without air injection, and capability for continuous multi-container delivery with infusion pump compatibility. Key differences include: subject device uses gamma sterilization versus predicate's ethylene oxide; subject has two separate fluid paths versus predicate's single path with six spikes; and subject accommodates 2–4 source containers versus predicate's 6 containers.
ISO 11137 (gamma sterilization validation), ISO 11135 (ethylene oxide sterilization), ISO 10993-1 (biocompatibility). Testing included leak, particulate, Luer connector compatibility, stopper fragmentation, sterile packaging, flow, residual volume, human factors validation, and biocompatibility endpoints (cytotoxicity, sensitization, pyrogenicity, hemolysis, acute/subacute toxicity).
The subject device shares the core intended function and technological design with the predicate: both are spike-based, multi-container vial access systems with hydrophobic air filters for needleless drug withdrawal. Although the subject uses different sterilization, has dual fluid paths instead of one, and accommodates fewer containers, Takeda demonstrates these differences do not raise new safety or effectiveness concerns through equivalent sterility assurance levels (10⁻⁶) and testing of fluid path performance, flow compatibility with pumps, and comprehensive biocompatibility across relevant exposure scenarios matching the predicate's blood-path-indirect contact classification.
View the full FDA submission: accessdata.fda.gov