Panels › Gastroenterology, Urology › Product code KPO · Class 2
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation 876.5820
2510(k)s in 12 months (124 all time)
15recalls in 12 months (113 all time)
113recalls that name a 510(k)
Top companies in KPO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2026 | K260799 | Nipro Dry Acid Concentrate Mixer Nipro Technical Solutions, Incoporated | KPO |
| Jan 29, 2026 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Sep 9, 2025 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bic Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 4, 2025 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bic Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jul 12, 2024 | K240920 | HemoCare Bicarbonate Concentrate Set (BCS) Deka Research and Development | KPO |
| May 10, 2024 | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jan 18, 2024 | K233213 | NxStage PureFlow Solution Nxstage Medical, Inc. | KPO |
| Dec 1, 2023 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Aug 4, 2023 | K223431 | Citric Complete Liquid Citric Acid Concentrate Nipro Renal Solutions USA, Corp. | KPO |
| Mar 3, 2023 | K221652 | NIKKICART Renal Care Dialysis Solutions, S.A. DE C.V., MX | KPO |
| Aug 12, 2022 | K202508 | Hemo-Lyte C Cartridge Di-Chem, Inc. | KPO |
| May 12, 2022 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jul 23, 2021 | K212052 | HMB32 Dialysis Solution Haemopharm Biofluids S.R.L., IT | KPO |
| Nov 25, 2020 | K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis Nipro Renal Solutions USA, Corp. | KPO |
| May 8, 2020 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 24, 2020 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Feb 24, 2020 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry B Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jan 22, 2020 | K191093 | Isopure Dry Acid Dissolution System Isopure, Corp. | KPO |
| Dec 7, 2018 | K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate a Global Scientific Technologies, LLC | KPO |
| Mar 6, 2018 | K171750 | Citric Complete Dry Citric Acid (45X) Dimesol USA, LLC | KPO |
| Oct 13, 2017 | K171015 | Citryte Di-Chem, Inc. | KPO |
| May 18, 2017 | K162716 | bibag Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jan 6, 2017 | K162887 | PrismaSATE Baxter Healthcare Corporation | KPO |
| Oct 20, 2016 | K160847 | Rockwell Medical CitraPure Acid Concetrate Rockwell Medical | KPO |
| Dec 4, 2015 | K150966 | HMB32 Haemopharm Biofluids S.R.L., IT | KPO |
| Apr 3, 2014 | K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X Dialysis Medical Solutions, LLC | KPO |
| Feb 10, 2014 | K130511 | CITRISOL ACID CONCENTRATE Diasol, Inc. | KPO |
| Aug 29, 2013 | K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS Fresenius Medical Care North America | KPO |
| May 25, 2012 | K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY Gambro Renal Products | KPO |
| Mar 29, 2012 | K120005 | ACDS Isopure, Corp. | KPO |
| Apr 25, 2011 | K102194 | SOLCART B B. Braun Avitum AG | KPO |
| Aug 7, 2009 | K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A Baxter Healthcare Corp | KPO |
| Feb 4, 2008 | K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY Gambro Renal Products | KPO |
| Jan 29, 2008 | K072760 | SOLCART B B. Braun Medizintechnologie GmbH | KPO |
| Jun 15, 2007 | K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB Fresenius Medical Care North America | KPO |
| Mar 29, 2007 | K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES Fresenius Medical Care North America | KPO |
| Nov 17, 2006 | K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE Rockwell Medical Technologies, Inc. | KPO |
| Dec 22, 2005 | K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. | KPO |
| Nov 9, 2005 | K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE B.Braun Medical, Inc. | KPO |
| Nov 2, 2005 | K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products | KPO |
| Aug 22, 2005 | K050827 | NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) Dialysis Solutions, Inc. | KPO |
| Aug 27, 2004 | K042045 | NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. | KPO |
| Aug 27, 2004 | K041683 | B. BRAUN BICARBONATE DIALYSATE B.Braun Medical, Inc. | KPO |
| Aug 27, 2004 | K041428 | ACCUSOL DIALYSIS SOLUTION Baxter Healthcare Corp | KPO |
| Mar 3, 2004 | K034066 | B.BRAUN PREMIXED DIALYSATE B.Braun Medical, Inc. | KPO |
| Nov 26, 2003 | K033386 | NXSTAGE PUREFLOW SOLUTION Nxstage Medical, Inc. | KPO |
| May 20, 2003 | K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES Fresenius Medical Care | KPO |
| Feb 28, 2003 | K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE Rockwell Medical Technologies, Inc. | KPO |
| Jan 3, 2003 | K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON Rockwell Medical Technologies, Inc. | KPO |
| Dec 23, 2002 | K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE Rockwell Medical Technologies, Inc. | KPO |
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