FDA cleared the Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) from Fresenius Medical Care Renal Therapies Group, LLC on Sep 9, 2025 under K252180, a traditional 510(k). The device falls under product code KPO, Dialysate Concentrate For Hemodialysis (Liquid Or Powder), regulated at 21 CFR 876.5820 as a Class 2 device. The review panel was Gastroenterology, Urology.
FDA logged the submission as received on Jul 11, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).
Fresenius Medical Care Renal Therapies Group, LLC has 8 other decisions in the tracker over the last 12 months: K261267 (Careflux H60;Careflux H70;Careflux V500), K252377 (NxStage System One with NxView), K252459 (multiFlux 130 (F00013123); multiFlux 160 (F00013124)), K253462 (NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)).
Questions & Answers
What did FDA clear under K252180?
K252180 is the FDA 510(k) for Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W), submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Sep 9, 2025, under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)).
Who makes the Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)?
Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K252180.
How long did the K252180 review take?
FDA received the submission on Jul 11, 2025 and issued its decision on Sep 9, 2025, 60 days later.