About This 510(k) Submission
K243505 is an FDA 510(k) clearance for the 5008X Hemodialysis System, 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 May 30, 2025, 199 days after receiving the submission on November 12, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.