510(k) K252459

multiFlux 130 (F00013123); multiFlux 160 (F00013124) by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K252459 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "multiFlux 130 (F00013123); multiFlux 160 (F00013124)". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.