# K230988: Vial2Bag Advanced® 13mm Admixture Device

- Pathway: 510(k) (Traditional)
- Applicant: West Pharma. Services IL, Ltd.
- Decided: Dec 1, 2023 after 239 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 K910793 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201415: Vial2Bag Advanced 20mm Admixture Device, West Pharmaceutical Services Az, Inc. (2020) Summary page 6.

## Most influential descendants
- K240940: Vial2Bag Advanced® 20mm Admixture Device (2024), 0 descendants of its own

## Indications for use
The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 13mm 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/K230988
Methodology: https://510kreport.com/methodology