Product Code: KPO FDA class 2 21 CFR 876.5820

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Gastroenterology, Urology

This device is a dialysate concentrate for hemodialysis, available in liquid or powder form, which is diluted with purified water to prepare the dialysis solution used to remove waste products and excess fluid from the blood in patients with kidney failure. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPO, regulated under 21 CFR 876.5820 within the Gastroenterology and Urology specialty. This device is designated as life-sustaining or life-supporting, reflecting its essential role in renal replacement therapy.

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510(k)s

123

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KPO
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 123 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253462	NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)	Jan 29, 2026	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K252180	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)	Sep 09, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K243786	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)	Apr 04, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K240920	HemoCare Bicarbonate Concentrate Set (BCS)	Jul 12, 2024	Substantially Equivalent	Deka Research and Development
K233950	pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)	May 10, 2024	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K233213	NxStage PureFlow Solution	Jan 18, 2024	Substantially Equivalent	Nxstage Medical, Inc.
K233159	pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504	Dec 01, 2023	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K223431	Citric Complete Liquid Citric Acid Concentrate	Aug 04, 2023	Substantially Equivalent	Nipro Renal Solutions USA, Corp.
K221652	NIKKICART	Mar 03, 2023	Substantially Equivalent	Renal Care Dialysis Solutions, S.A. DE C.V.
K202508	Hemo-Lyte C Cartridge	Aug 12, 2022	Substantially Equivalent	Di-Chem, Inc.
K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	May 12, 2022	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K212052	HMB32 Dialysis Solution	Jul 23, 2021	Substantially Equivalent	Haemopharm Biofluids S.R.L.
K193155	Nipro Dry Complete Dry Acid Concentrate for Hemodialysis	Nov 25, 2020	Substantially Equivalent	Nipro Renal Solutions USA, Corp.
K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	May 08, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K192017	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	Apr 24, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K191474	NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)	Feb 24, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K191093	Isopure Dry Acid Dissolution System	Jan 22, 2020	Substantially Equivalent	Isopure, Corp.
K180679	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)	Dec 07, 2018	Substantially Equivalent	Global Scientific Technologies, LLC
K171750	Citric Complete Dry Citric Acid (45X)	Mar 06, 2018	Substantially Equivalent	Dimesol USA, LLC
K171015	Citryte	Oct 13, 2017	Substantially Equivalent	Di-Chem, Inc.
K162716	bibag	May 18, 2017	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K162887	PrismaSATE	Jan 06, 2017	Substantially Equivalent	Baxter Healthcare Corporation
K160847	Rockwell Medical CitraPure Acid Concetrate	Oct 20, 2016	Substantially Equivalent	Rockwell Medical
K150966	HMB32	Dec 04, 2015	Substantially Equivalent	Haemopharm Biofluids S.R.L.
K131202	MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X	Apr 03, 2014	Substantially Equivalent	Dialysis Medical Solutions, LLC
K130511	CITRISOL ACID CONCENTRATE	Feb 10, 2014	Substantially Equivalent	Diasol, Inc.
K131611	FRESENIUS DRY ACID DISSOLUTION UNITS	Aug 29, 2013	Substantially Equivalent	Fresenius Medical Care North America
K120333	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY	May 25, 2012	Substantially Equivalent	Gambro Renal Products
K120005	ACDS	Mar 29, 2012	Substantially Equivalent	Isopure, Corp.
K102194	SOLCART B	Apr 25, 2011	Substantially Equivalent	B. Braun Avitum AG
K090002	ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A	Aug 07, 2009	Substantially Equivalent	Baxter Healthcare Corp
K072908	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY	Feb 04, 2008	Substantially Equivalent	Gambro Renal Products
K072760	SOLCART B	Jan 29, 2008	Substantially Equivalent	B. Braun Medizintechnologie GmbH
K071387	FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB	Jun 15, 2007	Substantially Equivalent	Fresenius Medical Care North America
K070177	FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES	Mar 29, 2007	Substantially Equivalent	Fresenius Medical Care North America
K062399	ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE	Nov 17, 2006	Substantially Equivalent	Rockwell Medical Technologies, Inc.
K053286	MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION	Dec 22, 2005	Substantially Equivalent	Nxstage Medical, Inc.
K052393	B. BRAUN MODIFIED BICARBONATE DIALYSATE	Nov 09, 2005	Substantially Equivalent	B.Braun Medical, Inc.
K052253	MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS	Nov 02, 2005	Substantially Equivalent	Gambro Renal Products
K050827	NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)	Aug 22, 2005	Substantially Equivalent	Dialysis Solutions, Inc.
K042045	NXSTAGE PUREFLOW-B SOLUTION	Aug 27, 2004	Substantially Equivalent	Nxstage Medical, Inc.
K041683	B. BRAUN BICARBONATE DIALYSATE	Aug 27, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K041428	ACCUSOL DIALYSIS SOLUTION	Aug 27, 2004	Substantially Equivalent	Baxter Healthcare Corp
K034066	B.BRAUN PREMIXED DIALYSATE	Mar 03, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K033386	NXSTAGE PUREFLOW SOLUTION	Nov 26, 2003	Substantially Equivalent	Nxstage Medical, Inc.
K030497	FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES	May 20, 2003	Substantially Equivalent	Fresenius Medical Care
K023985	ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE	Feb 28, 2003	Substantially Equivalent	Rockwell Medical Technologies, Inc.
K022521	BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON	Jan 03, 2003	Substantially Equivalent	Rockwell Medical Technologies, Inc.
K022500	DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE	Dec 23, 2002	Substantially Equivalent	Rockwell Medical Technologies, Inc.
K022913	NXSTAGE PREMIXED DIALYSATE	Oct 21, 2002	Substantially Equivalent	Nxstage Medical, Inc.
K020231	DIASOL-ADDITIVES	Oct 21, 2002	Substantially Equivalent	Diasol, Inc.
K020230	DIASOL-BICARB	Apr 23, 2002	Substantially Equivalent	Diasol, Inc.
K013655	NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100	Feb 04, 2002	Substantially Equivalent	Nxstage Medical, Inc.
K012547	HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION	Jan 18, 2002	Substantially Equivalent	Di-Chem, Inc.
K012328	HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER	Jan 18, 2002	Substantially Equivalent	Di-Chem, Inc.
K013448	PRISMASATE	Jan 15, 2002	Substantially Equivalent	Gambro Renal Products
K013724	BICART	Jan 08, 2002	Substantially Equivalent	Gambro Renal Products
K011368	DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS	Aug 02, 2001	Substantially Equivalent	Gambro Renal Products
K010760	ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS	Jun 11, 2001	Substantially Equivalent	Advanced Renal Technologies, Inc.
K001059	NORMOCARB STERILE BICARBONATE RENAL DIALYSIS	Jun 30, 2000	Substantially Equivalent	Novex Pharma
K000792	CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX	Jun 08, 2000	Substantially Equivalent	Advanced Renal Technologies, Inc.
K993212	DRYASOL ACID CONCENTRATE MIX	Oct 22, 1999	Substantially Equivalent	Diasol, Inc.
K983618	DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE	Aug 05, 1999	Substantially Equivalent	Rockwell Medical Technologies, Inc.
K990507	ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER	May 07, 1999	Substantially Equivalent	Althin Biopharm, Inc.
K990010	ALTHIN MEDICAL AB ALTRACART II	Apr 15, 1999	Substantially Equivalent	Althin Medical AB
K982813	NATURALYTE, MODEL # 08-4004-1	Nov 06, 1998	Substantially Equivalent	Kaybath, Inc.
K982378	HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE	Aug 26, 1998	Substantially Equivalent	Solution Technologies
K981003	ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES	Jun 16, 1998	Substantially Equivalent	International Medical Products, Inc.
K980659	DRYALYSATE CONCENTRATE	Jun 11, 1998	Substantially Equivalent	Advanced Renal Technologies, Inc.
K981043	DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL	May 26, 1998	Substantially Equivalent	Solution Technologies
K973253	ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE	Oct 30, 1997	Substantially Equivalent	International Medical Products, Inc.
K971053	ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS	Jun 16, 1997	Substantially Equivalent	International Medical Products, Inc.
K954527	ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS	Mar 01, 1996	Substantially Equivalent	Rockwell Medical Supply
K922088	FRESENIUS DIALYSATE ACID CONCENTRATE	Oct 17, 1994	Substantially Equivalent	Fresenius USA, Inc.
K941958	WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE	Sep 30, 1994	Substantially Equivalent	Western Dialysis Supplies , Ltd.
K922990	HEMODIALYSIS BATH	Sep 12, 1994	Substantially Equivalent	Medi-Tech, Inc.
K922005	GRANULYTE DIALYSATE CONCENTRATE	Mar 30, 1994	Substantially Equivalent	Fresenius USA, Inc.
K940601	GAMBRO BICART 720G	Mar 22, 1994	Substantially Equivalent	C.G.H. Medical, Inc.
K911459	GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING	Jul 17, 1991	Substantially Equivalent	Fresenius USA, Inc.
K903835	ACETATE-FREE DIALYSLATE SOLUTION	Jul 05, 1991	Substantially Equivalent	Physio, Inc.
K910319	ACID CONCENTRATE SOLUTIONS	Apr 24, 1991	Substantially Equivalent	Biopharm, Inc.
K910270	PREMIXED DIALYSATE FOR HEMODIAFILTRATION	Apr 18, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904946	HAEMODIALYSIS CONCENTRATE	Apr 09, 1991	Substantially Equivalent	Bdh, Inc.
K905021	ACETATE CONCENTRATES FOR HEMODIALYSIS	Mar 15, 1991	Substantially Equivalent	Medical Components, Inc.
K901473	GC-01 THROUGH GC-99 ACETATE CONCENTRATE	Jul 27, 1990	Substantially Equivalent	Granite Chemical Co., Inc.
K901472	GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS	Jul 27, 1990	Substantially Equivalent	Granite Chemical Co., Inc.
K901471	GC-1000 THROUGH GC-3005 ACID CONCENTRATE	Jul 27, 1990	Substantially Equivalent	Granite Chemical Co., Inc.
K893991	HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS	Jan 11, 1990	Substantially Equivalent	P & A Co.
K896111	FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB	Dec 27, 1989	Substantially Equivalent	Fresenius USA, Inc.
K895199	BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE	Dec 13, 1989	Substantially Equivalent	Baxter Healthcare Corp
K891921	BICARBONATE CONCENTRATE POWDER	Apr 17, 1989	Substantially Equivalent	Haemolyte, Inc.
K891159	SODIUM BICARBONATE, U.S.P.	Apr 07, 1989	Substantially Equivalent	Williams Medical Co.
K884725	BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS	Jan 30, 1989	Substantially Equivalent	Baxter Healthcare Corp
K883068	HEMODIALYSIS CONCENTRATES	Dec 22, 1988	Substantially Equivalent	Dove Medical Supplies
K880102	BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS	May 26, 1988	Substantially Equivalent	Baxter Healthcare Corp
K872857	HOSPAL DIALYSATE FOR C.A.V.H.D.	Oct 05, 1987	Substantially Equivalent	Delmed, Inc.
K870979	HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS	Jun 03, 1987	Substantially Equivalent	Inventory Supply Corp.
K865078	POWDERED BICARBONATE CONCENTRATE	Mar 27, 1987	Substantially Equivalent	Bicarbolyte Corp.
K864265	HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI	Mar 17, 1987	Substantially Equivalent	Dial Medical of Florida, Inc.
K864942	BICARBONATE MIXING SYSTEM	Mar 10, 1987	Substantially Equivalent	Morris Tool , Ltd.
K863631	SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS	Oct 16, 1986	Substantially Equivalent	American Healthcare Corp.
K861156	HOSPAL DIALYSATE FOR CAVHD	Sep 23, 1986	Substantially Equivalent	Hospal Medical Corp.
K852955	HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD	Feb 05, 1986	Substantially Equivalent	Renalchem, Inc.
K854206	ULTRACLONE 05-100 GUINEA PIG RBC	Oct 31, 1985	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K851431	HEMODIALYSIS CONCENTRATE ADDITIVES	Jun 12, 1985	Substantially Equivalent	Dana Laboratories
K843866	HEMODIALYSATE SOLUTIONS	Jan 09, 1985	Substantially Equivalent	Bicarbolyte Corp.
K834538	LAS-2 ALIGNMENT SYSTEM	Feb 21, 1984	Substantially Equivalent	Therados, Inc.
K832866	HEMO-DIAL	Nov 03, 1983	Substantially Equivalent	Cmi Pharmaceuticals, Inc.
K823779	DIALYTE	Jan 17, 1983	Substantially Equivalent	Renal Dynamics, Inc.
K823103	DIALYSATE ADDITIVES-POWDER/LIQUID	Nov 17, 1982	Substantially Equivalent	Di-Chem, Inc.
K821304	CENTRALYTE BICARBONATE CONCENTRATE	May 18, 1982	Substantially Equivalent	Erika, Inc.
K820150	K-AID	Jan 29, 1982	Substantially Equivalent	Sytek Laboratories
K813586	DIALYSIS CONCENTRATE	Jan 29, 1982	Substantially Equivalent	Diversified Medical Services
K813388	HEMODIALYSATE	Dec 31, 1981	Substantially Equivalent	Edlaw Pharmaceuticals, Inc.
K811706	LACTIC ACID DIALYSATE ADDITIVE	Sep 24, 1981	Substantially Equivalent	Edlaw Pharmaceuticals, Inc.
K810925	NATURALYTE BICARBONATE DIALYSATE CONCEN.	Apr 23, 1981	Substantially Equivalent	Erika, Inc.
K810527	CHEM-DIALYTE CONCENTRATES	Apr 23, 1981	Substantially Equivalent	Luchem Pharmaceuticals, Inc.
K810280	DIALYSATE CONCENTRATE FOR HEMODIALYSIS	Feb 19, 1981	Substantially Equivalent	Cobe Laboratories, Inc.
K800624	LOW-ACETATE HEMODIALYSIS BATH CONCENTR.	Jul 14, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K792513	HEMODIALYSIS CONCENTRATE SOLUTION	Apr 08, 1980	Substantially Equivalent	Mid Atlantic Nephrology Center
K792213	RENAL SYSTEMS HEMODIALYSIS CONCENTRATE	Jan 04, 1980	Substantially Equivalent	Renal Systems, Inc.
K781967	HEMODIALYSIS CONCENTRATE, SODIU	Dec 07, 1978	Substantially Equivalent	Renal Systems, Inc.
K780353	DRI-LYTE	Apr 05, 1978	Substantially Equivalent	Mallinckrodt Critical Care