FDA cleared the Medline Bag Decanter from Medline Industries, LP on Oct 24, 2025 under K250345, a traditional 510(k). The device falls under product code LHI, Set, I.V. Fluid Transfer, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Feb 6, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Medline Industries, LP has 5 other decisions in the tracker over the last 12 months: K253526 (NAMIC Dilator and Sheath), K254287 (Medline Reusable Blood Pressure Cuff), K253322 (Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)), K251687 (Konig Bell Circumcision Clamp).