510(k) 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) by Microtek Medical, LLC — Product Code LHI

K251676 is an FDA 510(k) premarket notification submitted by Microtek Medical, LLC for the device "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)". The FDA issued a decision of Substantially Equivalent on September 16, 2025. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Microtek Medical, LLC has at least 10 other 510(k) clearances on record.