510(k) K242053

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K242053 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)". The FDA issued a decision of Substantially Equivalent on March 21, 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.