Data / Medical devices / United States / Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.: FDA-registered device maker in Cambridge, MA, United States, 3 510(k) clearances
Takeda Pharmaceuticals U.S.A., Inc. is registered with the FDA (registration 3016418550) in Cambridge, MA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016418550
- Address
- 500 Kendall Street, Cambridge, MA, United States, 02142
- Owner or operator
- Takeda Pharmaceuticals U.S.A., Inc. (10079762)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2020
- Registered through
- 2026
- Brand names listed
- Baxject II Hi-Flow Needleless Transfer Device, Baxject II Needleless Transfer Device, HyHub and HyHub Duo Vial Access Devices, Recombinant Factor VIII Substrate, Porcine Sequence, Takeda Convenience Kit, myPKFiT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Specification developer | accessdata.fda.gov |
| Parenteral Administration Kit | POR | 2 | Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | accessdata.fda.gov |
| Sparse Sample Pk Profile And Dosing Software | PHY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2025 | K243404 | HyHub and HyHub Duo Vial Access Devices | LHI | Substantially Equivalent | Takeda Pharmaceuticals | accessdata.fda.gov |
| October 30, 2009 | K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2004 | K042410 | BAXJECT II | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Control, Plasma, Abnormal
- All makers of Parenteral Administration Kit
Updated July 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.