About This 510(k) Submission
K243786 is an FDA 510(k) clearance for the Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G), a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on April 4, 2025, 116 days after receiving the submission on December 9, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.