Cleared Traditional

K243786 - Bicarby Dialysate RFP-402 (RFP-402-G) (FDA 510(k) Clearance)

Also includes:

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)

K243786 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device

Apr 2025

Decision

116d

Days

Class 2

Risk

K243786 is an FDA 510(k) clearance for the Bicarby Dialysate RFP-402 (RFP-402-G). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K243786 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 09, 2024
Decision Date	April 04, 2025
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF