# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, LLC
- Decided: Sep 16, 2025 after 109 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
Microtek decanters are intended for the aseptic transfer of solutions (eg. IV fluids and medications) from IV containers • Bag decanters are for use in transferring IV fluids and medication from a bag to an IV fluid administration device. • Vial decanters are for use in transferring IV fluids and medications from a vial to an IV fluid administration device. • Transfer devices are for use in transferring IV fluids and medications from a vial or medication container to an IV fluid administration device. Microtek decanters are suitable for adult and pediatric patients. The use of decanters is at the discretion of the healthcare professional.

Source page: https://510kreport.com/device/K251676
Methodology: https://510kreport.com/methodology