# K201415: Vial2Bag Advanced 20mm Admixture Device

- Pathway: 510(k) (Traditional)
- Applicant: West Pharmaceutical Services Az, Inc.
- Decided: Oct 21, 2020 after 145 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910793 (1991). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142600: VIAL-MATE Adaptor, Baxter Healthcare Corporation (2014) Summary page 5.

## Most influential descendants
- K230988: Vial2Bag Advanced® 13mm Admixture Device (2023), 1 descendant of its own
- K252987: ADRx™ Admixture Device (2026), 0 descendants of its own
- K240940: Vial2Bag Advanced® 20mm Admixture Device (2024), 0 descendants of its own
- K212525: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (2022), 0 descendants of its own
- K212445: freeflex+ Transfer Adapter (2022), 0 descendants of its own

## Recalls of this device
- Sep 24, 2024 · Class II · Z-0283-2025: Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

## 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.

Source page: https://510kreport.com/device/K201415
Methodology: https://510kreport.com/methodology