510(k) K243505

5008X Hemodialysis System by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K243505 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "5008X Hemodialysis System". The FDA issued a decision of Substantially Equivalent on May 30, 2025. 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.