About This 510(k) Submission
K253518 is an FDA 510(k) clearance for the FX CorAL 40; FX CorAL 50, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on December 18, 2025, 36 days after receiving the submission on November 12, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.