# K182819: Decanting Device

- Pathway: 510(k) (Traditional)
- Applicant: Gcmedica Enterprise Ltd.(Wuxi)
- Decided: Dec 2, 2019 after 424 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 K111577 (2011). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111577: Medline Vial Decanter, Medline Industries, Inc. (2011) Summary page 5.

## Most influential descendants
- K250345: Medline Bag Decanter (2025), 0 descendants of its own
- K251676: Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (2025), 0 descendants of its own

## Indications for use
GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

Source page: https://510kreport.com/device/K182819
Methodology: https://510kreport.com/methodology