510(k) K253518

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

K253518 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "FX CorAL 40; FX CorAL 50". The FDA issued a decision of Substantially Equivalent on December 18, 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.