# K231071: Mix2Vial® Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: West Pharma. Services IL, Ltd.
- Decided: Jan 19, 2024 after 280 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: 1 generation back to K031861 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031861: MIX2VIAL Transfer Device, Medimop Medical Projects, Ltd. (2003) Summary page 4.

## Indications for use
The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.

Source page: https://510kreport.com/device/K231071
Methodology: https://510kreport.com/methodology