KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Class 2 Life-Sustaining

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (123)

Device Name	Manufacturer	K-Number	Decision Date
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)	Fresenius Medical Care Renal Therapies Group, LLC	K253462	2026-01-29
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	K252180	2025-09-09
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)	Fresenius Medical Care Renal Therapies Group, LLC	K243786	2025-04-04
HemoCare Bicarbonate Concentrate Set (BCS)	Deka Research and Development	K240920	2024-07-12
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)	Fresenius Medical Care Renal Therapies Group, LLC	K233950	2024-05-10
NxStage PureFlow Solution	Nxstage Medical, Inc.	K233213	2024-01-18
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504	Fresenius Medical Care Renal Therapies Group, LLC	K233159	2023-12-01
Citric Complete Liquid Citric Acid Concentrate	Nipro Renal Solutions USA, Corp.	K223431	2023-08-04
NIKKICART	Renal Care Dialysis Solutions, S.A. DE C.V.	K221652	2023-03-03
Hemo-Lyte C Cartridge	Di-Chem, Inc.	K202508	2022-08-12
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	K212620	2022-05-12
HMB32 Dialysis Solution	Haemopharm Biofluids S.R.L.	K212052	2021-07-23
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis	Nipro Renal Solutions USA, Corp.	K193155	2020-11-25
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	K192209	2020-05-08
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	K192017	2020-04-24
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)	Fresenius Medical Care Renal Therapies Group, LLC	K191474	2020-02-24
Isopure Dry Acid Dissolution System	Isopure, Corp.	K191093	2020-01-22
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)	Global Scientific Technologies, LLC	K180679	2018-12-07
Citric Complete Dry Citric Acid (45X)	Dimesol USA, LLC	K171750	2018-03-06
Citryte	Di-Chem, Inc.	K171015	2017-10-13

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