# K250345: Medline Bag Decanter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Oct 24, 2025 after 260 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: 2 generations back to K111577 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182819: Decanting Device, Gcmedica Enterprise Ltd.(Wuxi) (2019) Summary page 5.

## Indications for use
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/K250345
Methodology: https://510kreport.com/methodology