# K243404: HyHub™ and HyHub™ Duo Vial Access Devices

- Pathway: 510(k) (Traditional)
- Applicant: Takeda Pharmaceuticals
- Decided: Jul 18, 2025 after 259 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903493 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040456: Fleboset Multiple, Laboratorios Grifols, S.A. (2004) Summary page 5.

## Indications for use
HyHub™ and HyHub™ Duo vial access devices are indicated for patients 17 years of age or older to allow a drug to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

Source page: https://510kreport.com/device/K243404
Methodology: https://510kreport.com/methodology