# K212525: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices

- Pathway: 510(k) (Traditional)
- Applicant: Advcare Medical
- Decided: Aug 19, 2022 after 373 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.
No later device cites it as a predicate yet.
0 of 5 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 4.

## Indications for use
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer infusion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.

Source page: https://510kreport.com/device/K212525
Methodology: https://510kreport.com/methodology