Product code KPO

Device name: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5820
Review panel: GU
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K253462	NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)	Fresenius Medical Care Renal Therapies Group, LLC	2026-01-29
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); Bic...	Fresenius Medical Care Renal Therapies Group, LLC	2025-09-09
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-...	Fresenius Medical Care Renal Therapies Group, LLC	2025-04-04
K240920	HemoCare Bicarbonate Concentrate Set (BCS)	Deka Research and Development	2024-07-12
K233950	pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)	Fresenius Medical Care Renal Therapies Group, LLC	2024-05-10
K233213	NxStage PureFlow Solution	Nxstage Medical, Inc.	2024-01-18
K233159	pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504	Fresenius Medical Care Renal Therapies Group, LLC	2023-12-01
K223431	Citric Complete Liquid Citric Acid Concentrate	Nipro Renal Solutions USA, Corp.	2023-08-04
K221652	NIKKICART	Renal Care Dialysis Solutions, S.A. DE C.V.	2023-03-03
K202508	Hemo-Lyte C Cartridge	Di-Chem, Inc.	2022-08-12
K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	2022-05-12
K212052	HMB32 Dialysis Solution	Haemopharm Biofluids S.R.L.	2021-07-23
K193155	Nipro Dry Complete Dry Acid Concentrate for Hemodialysis	Nipro Renal Solutions USA, Corp.	2020-11-25
K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	2020-05-08
K192017	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	2020-04-24
K191474	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	2020-02-24
K191093	Isopure Dry Acid Dissolution System	Isopure, Corp.	2020-01-22
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 Po...	Global Scientific Technologies, LLC	2018-12-07
K171750	Citric Complete Dry Citric Acid (45X)	Dimesol USA, LLC	2018-03-06
K171015	Citryte	Di-Chem, Inc.	2017-10-13
K162716	bibag	Fresenius Medical Care Renal Therapies Group, LLC	2017-05-18
K162887	PrismaSATE	Baxter Healthcare Corporation	2017-01-06
K160847	Rockwell Medical CitraPure Acid Concetrate	Rockwell Medical	2016-10-20
K150966	HMB32	Haemopharm Biofluids S.R.L.	2015-12-04
K131202	MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X	Dialysis Medical Solutions, LLC	2014-04-03
K130511	CITRISOL ACID CONCENTRATE	Diasol, Inc.	2014-02-10
K131611	FRESENIUS DRY ACID DISSOLUTION UNITS	Fresenius Medical Care North America	2013-08-29
K120333	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY	Gambro Renal Products	2012-05-25
K120005	ACDS	Isopure, Corp.	2012-03-29
K102194	SOLCART B	B. Braun Avitum AG	2011-04-25

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M535RFP211WW0	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2018-10-01
10857940006039	Hemo-Dial	EDLAW PHARMACEUTICALS, INC.	2016-09-23
10857940006022	Hemo-Dial	EDLAW PHARMACEUTICALS, INC.	2016-09-23
10857940006015	Hemo-Dial	EDLAW PHARMACEUTICALS, INC.	2016-09-23
M535RFP207CAN0	PUREFLOW DIALYSATE	NXSTAGE MEDICAL, INC.	2016-07-21
M535RFP209CAN0	PUREFLOW DIALYSATE	NXSTAGE MEDICAL, INC.	2016-07-21
M535RFP204CAN0	PUREFLOW DIALYSATE	NXSTAGE MEDICAL, INC.	2016-07-21
09349285000185	ACCUSOL Dialysis Solution for CRRT	Nikkiso Belgium BVBA	2016-06-30
09349285000192	ACCUSOL Dialysis Solution for CRRT	Nikkiso Belgium BVBA	2016-06-30
09349285000208	Premixed Dialysate for Hemodiafiltration	Nikkiso Belgium BVBA	2016-06-30
M535RFP4000	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-02
M535RFP4010	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4560	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4550	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4540	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4530	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4060	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4050	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4040	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4030	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP4020	NxStage PureFlow B Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP2040	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP2110	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP209WW0	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP2090	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP207WW0	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP2070	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP205WW0	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP2050	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01
M535RFP204WW0	NxStage PureFlow Solution	NXSTAGE MEDICAL, INC.	2015-09-01

Product code KPO

Related 510(k) Records#

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