# K240940: Vial2Bag Advanced® 20mm Admixture Device

- Pathway: 510(k) (Special)
- Applicant: West Pharmaceutical Services, Inc.
- Decided: May 3, 2024 after 28 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: 5 generations back to K910793 (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)
- K230988: Vial2Bag Advanced® 13mm Admixture Device, West Pharma. Services IL, Ltd. (2023) Summary page 5.

## Indications for use
The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

Source page: https://510kreport.com/device/K240940
Methodology: https://510kreport.com/methodology