FDA 510(k) Applications for Medical Device Product Code "KPO"
(Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K010760 | ADVANCED RENAL TECHNOLOGIES, INC. | ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS | 06/11/2001 |
| K000792 | ADVANCED RENAL TECHNOLOGIES, INC. | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX | 06/08/2000 |
| K980659 | ADVANCED RENAL TECHNOLOGIES, INC. | DRYALYSATE CONCENTRATE | 06/11/1998 |
| K990507 | ALTHIN BIOPHARM, INC. | ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER | 05/07/1999 |
| K990010 | ALTHIN MEDICAL AB | ALTHIN MEDICAL AB ALTRACART II | 04/15/1999 |
| K102194 | B. BRAUN AVITUM AG | SOLCART B | 04/25/2011 |
| K041683 | B. BRAUN MEDICAL, INC. | B. BRAUN BICARBONATE DIALYSATE | 08/27/2004 |
| K052393 | B. BRAUN MEDICAL, INC. | B. BRAUN MODIFIED BICARBONATE DIALYSATE | 11/09/2005 |
| K034066 | B. BRAUN MEDICAL, INC. | B.BRAUN PREMIXED DIALYSATE | 03/03/2004 |
| K072760 | B. BRAUN MEDIZINTECHNOLOGIE GMBH | SOLCART B | 01/29/2008 |
| K041428 | BAXTER HEALTHCARE CORP. | ACCUSOL DIALYSIS SOLUTION | 08/27/2004 |
| K090002 | BAXTER HEALTHCARE CORP. | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A | 08/07/2009 |
| K162887 | Baxter Healthcare Corporation | PrismaSATE | 01/06/2017 |
| K171015 | Di-Chem, Inc. | Citryte | 10/13/2017 |
| K202508 | Di-Chem, Inc. | Hemo-Lyte C Cartridge | 08/12/2022 |
| K012328 | DI-CHEM, INC. | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | 01/18/2002 |
| K012547 | DI-CHEM, INC. | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | 01/18/2002 |
| K131202 | DIALYSIS MEDICAL SOLUTIONS, LLC | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X | 04/03/2014 |
| K050827 | DIALYSIS SOLUTIONS, INC. | NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) | 08/22/2005 |
| K130511 | DIASOL, INC. | CITRISOL ACID CONCENTRATE | 02/10/2014 |
| K020231 | DIASOL, INC. | DIASOL-ADDITIVES | 10/21/2002 |
| K020230 | DIASOL, INC. | DIASOL-BICARB | 04/23/2002 |
| K993212 | DIASOL, INC. | DRYASOL ACID CONCENTRATE MIX | 10/22/1999 |
| K171750 | Dimesol USA, LLC | Citric Complete Dry Citric Acid (45X) | 03/06/2018 |
| K030497 | FRESENIUS MEDICAL CARE | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | 05/20/2003 |
| K131611 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS DRY ACID DISSOLUTION UNITS | 08/29/2013 |
| K070177 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | 03/29/2007 |
| K071387 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB | 06/15/2007 |
| K162716 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC | bibag | 05/18/2017 |
| K192209 | Fresenius Medical Care Renal Therapies Group, LLC | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | 05/08/2020 |
| K192017 | Fresenius Medical Care Renal Therapies Group, LLC | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | 04/24/2020 |
| K212620 | Fresenius Medical Care Renal Therapies Group, LLC | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | 05/12/2022 |
| K191474 | Fresenius Medical Care Renal Therapies Group, LLC | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | 02/24/2020 |
| K013724 | GAMBRO RENAL PRODUCTS | BICART | 01/08/2002 |
| K011368 | GAMBRO RENAL PRODUCTS | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | 08/02/2001 |
| K052253 | GAMBRO RENAL PRODUCTS | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | 11/02/2005 |
| K013448 | GAMBRO RENAL PRODUCTS | PRISMASATE | 01/15/2002 |
| K120333 | GAMBRO RENAL PRODUCTS | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY | 05/25/2012 |
| K072908 | GAMBRO RENAL PRODUCTS | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | 02/04/2008 |
| K180679 | Global Scientific Technologies, LLC | 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 Conc | 12/07/2018 |
| K212052 | Haemopharm Biofluids S.r.l. | HMB32 Dialysis Solution | 07/23/2021 |
| K150966 | HAEMOPHARM BIOFLUIDS SRL | HMB32 | 12/04/2015 |
| K973253 | INTERNATIONAL MEDICAL PRODUCTS, INC. | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | 10/30/1997 |
| K981003 | INTERNATIONAL MEDICAL PRODUCTS, INC. | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | 06/16/1998 |
| K971053 | INTERNATIONAL MEDICAL PRODUCTS, INC. | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | 06/16/1997 |
| K120005 | ISOPURE CORP. | ACDS | 03/29/2012 |
| K191093 | Isopure, Corp. | Isopure Dry Acid Dissolution System | 01/22/2020 |
| K982813 | KAYBATH, INC. | NATURALYTE, MODEL # 08-4004-1 | 11/06/1998 |
| K223431 | Nipro Renal Solutions USA, Corp. | Citric Complete Liquid Citric Acid Concentrate | 08/04/2023 |
| K193155 | Nipro Renal Solutions USA, Corp. | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | 11/25/2020 |
| K001059 | NOVEX PHARMA | NORMOCARB STERILE BICARBONATE RENAL DIALYSIS | 06/30/2000 |
| K053286 | NXSTAGE MEDICAL, INC. | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | 12/22/2005 |
| K013655 | NXSTAGE MEDICAL, INC. | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 | 02/04/2002 |
| K022913 | NXSTAGE MEDICAL, INC. | NXSTAGE PREMIXED DIALYSATE | 10/21/2002 |
| K033386 | NXSTAGE MEDICAL, INC. | NXSTAGE PUREFLOW SOLUTION | 11/26/2003 |
| K042045 | NXSTAGE MEDICAL, INC. | NXSTAGE PUREFLOW-B SOLUTION | 08/27/2004 |
| K221652 | Renal Care Dialysis Solutions, S.A. DE C.V. | NIKKICART | 03/03/2023 |
| K160847 | ROCKWELL MEDICAL | Rockwell Medical CitraPure Acid Concetrate | 10/20/2016 |
| K954527 | ROCKWELL MEDICAL SUPPLY | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | 03/01/1996 |
| K023985 | ROCKWELL MEDICAL TECHNOLOGIES, INC. | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE | 02/28/2003 |
| K022521 | ROCKWELL MEDICAL TECHNOLOGIES, INC. | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON | 01/03/2003 |
| K022500 | ROCKWELL MEDICAL TECHNOLOGIES, INC. | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | 12/23/2002 |
| K983618 | ROCKWELL MEDICAL TECHNOLOGIES, INC. | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE | 08/05/1999 |
| K062399 | ROCKWELL MEDICAL TECHNOLOGIES, INC. | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | 11/17/2006 |
| K981043 | SOLUTION TECHNOLOGIES | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL | 05/26/1998 |
| K982378 | SOLUTION TECHNOLOGIES | HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE | 08/26/1998 |
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