FDA Product Code
FDA Product Code KPO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 124 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | 2026-08-19 | Traditional | PDF ↗ |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 | Traditional | PDF ↗ |
| 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) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 | Traditional | PDF ↗ |
| 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) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 | Traditional | PDF ↗ |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | 2024-07-12 | Traditional | PDF ↗ |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 | Traditional | PDF ↗ |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 | Traditional | PDF ↗ |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023-08-04 | Traditional | PDF ↗ |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023-03-03 | Traditional | PDF ↗ |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022-08-12 | Traditional | PDF ↗ |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 | Traditional | PDF ↗ |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | 2021-07-23 | Special | PDF ↗ |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | 2020-11-25 | Traditional | PDF ↗ |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 | Traditional | PDF ↗ |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | 2020-01-22 | Traditional | PDF ↗ |
| 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) | Global Scientific Technologies, LLC | 2018-12-07 | Traditional | PDF ↗ |
| K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018-03-06 | Traditional | PDF ↗ |
| K171015 | Citryte | Di-Chem, Inc. | 2017-10-13 | Traditional | PDF ↗ |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | 2017-05-18 | Traditional | PDF ↗ |
| K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017-01-06 | Special | PDF ↗ |
| K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016-10-20 | Traditional | PDF ↗ |
| K150966 | HMB32 | Haemopharm Biofluids S.R.L. | 2015-12-04 | Traditional | PDF ↗ |
| K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X | Dialysis Medical Solutions, LLC | 2014-04-03 | Traditional | PDF ↗ |
| K130511 | CITRISOL ACID CONCENTRATE | Diasol, Inc. | 2014-02-10 | Traditional | PDF ↗ |
| K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS | Fresenius Medical Care North America | 2013-08-29 | Traditional | PDF ↗ |
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY | Gambro Renal Products | 2012-05-25 | Traditional | PDF ↗ |
| K120005 | ACDS | Isopure, Corp. | 2012-03-29 | Special | PDF ↗ |
| K102194 | SOLCART B | B. Braun Avitum AG | 2011-04-25 | Traditional | PDF ↗ |
| K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A | Baxter Healthcare Corp | 2009-08-07 | Traditional | PDF ↗ |
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | Gambro Renal Products | 2008-02-04 | Traditional | PDF ↗ |
| K072760 | SOLCART B | B. Braun Medizintechnologie GmbH | 2008-01-29 | Traditional | PDF ↗ |
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB | Fresenius Medical Care North America | 2007-06-15 | Special | PDF ↗ |
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | Fresenius Medical Care North America | 2007-03-29 | Special | PDF ↗ |
| K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | Rockwell Medical Technologies, Inc. | 2006-11-17 | Traditional | PDF ↗ |
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2005-12-22 | Special | PDF ↗ |
| K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE | B.Braun Medical, Inc. | 2005-11-09 | Special | PDF ↗ |
| K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | Gambro Renal Products | 2005-11-02 | Special | PDF ↗ |
| K050827 | NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) | Dialysis Solutions, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K042045 | NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2004-08-27 | Special | PDF ↗ |
| K041683 | B. BRAUN BICARBONATE DIALYSATE | B.Braun Medical, Inc. | 2004-08-27 | Traditional | PDF ↗ |
| K041428 | ACCUSOL DIALYSIS SOLUTION | Baxter Healthcare Corp | 2004-08-27 | Traditional | PDF ↗ |
| K034066 | B.BRAUN PREMIXED DIALYSATE | B.Braun Medical, Inc. | 2004-03-03 | Traditional | PDF ↗ |
| K033386 | NXSTAGE PUREFLOW SOLUTION | Nxstage Medical, Inc. | 2003-11-26 | Special | PDF ↗ |
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | Fresenius Medical Care | 2003-05-20 | Traditional | PDF ↗ |
| K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE | Rockwell Medical Technologies, Inc. | 2003-02-28 | Traditional | PDF ↗ |
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON | Rockwell Medical Technologies, Inc. | 2003-01-03 | Traditional | PDF ↗ |
| K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | Rockwell Medical Technologies, Inc. | 2002-12-23 | Traditional | PDF ↗ |
| K020231 | DIASOL-ADDITIVES | Diasol, Inc. | 2002-10-21 | Traditional | PDF ↗ |
| K022913 | NXSTAGE PREMIXED DIALYSATE | Nxstage Medical, Inc. | 2002-10-21 | Traditional | PDF ↗ |
| K020230 | DIASOL-BICARB | Diasol, Inc. | 2002-04-23 | Traditional | PDF ↗ |
| K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 | Nxstage Medical, Inc. | 2002-02-04 | Traditional | PDF ↗ |
| K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | Di-Chem, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Di-Chem, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013448 | PRISMASATE | Gambro Renal Products | 2002-01-15 | Traditional | PDF ↗ |
| K013724 | BICART | Gambro Renal Products | 2002-01-08 | Traditional | PDF ↗ |
| K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | Gambro Renal Products | 2001-08-02 | Traditional | PDF ↗ |
| K010760 | ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS | Advanced Renal Technologies, Inc. | 2001-06-11 | Traditional | PDF ↗ |
| K001059 | NORMOCARB STERILE BICARBONATE RENAL DIALYSIS | Novex Pharma | 2000-06-30 | Traditional | PDF ↗ |
| K000792 | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX | Advanced Renal Technologies, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K993212 | DRYASOL ACID CONCENTRATE MIX | Diasol, Inc. | 1999-10-22 | Special | PDF ↗ |
| K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE | Rockwell Medical Technologies, Inc. | 1999-08-05 | Traditional | PDF ↗ |
| K990507 | ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER | Althin Biopharm, Inc. | 1999-05-07 | Traditional | PDF ↗ |
| K990010 | ALTHIN MEDICAL AB ALTRACART II | Althin Medical AB | 1999-04-15 | Traditional | PDF ↗ |
| K982813 | NATURALYTE, MODEL # 08-4004-1 | Kaybath, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K982378 | HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE | Solution Technologies | 1998-08-26 | Traditional | PDF ↗ |
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | International Medical Products, Inc. | 1998-06-16 | Traditional | PDF ↗ |
| K980659 | DRYALYSATE CONCENTRATE | Advanced Renal Technologies, Inc. | 1998-06-11 | Traditional | PDF ↗ |
| K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL | Solution Technologies | 1998-05-26 | Traditional | PDF ↗ |
| K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | International Medical Products, Inc. | 1997-10-30 | Traditional | PDF ↗ |
| K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | International Medical Products, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K954527 | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | Rockwell Medical Supply | 1996-03-01 | Traditional | PDF ↗ |
| K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE | Fresenius USA, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K941958 | WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE | Western Dialysis Supplies , Ltd. | 1994-09-30 | Traditional | PDF ↗ |
| K922990 | HEMODIALYSIS BATH | Medi-Tech, Inc. | 1994-09-12 | Traditional | PDF ↗ |
| K922005 | GRANULYTE DIALYSATE CONCENTRATE | Fresenius USA, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K940601 | GAMBRO BICART 720G | C.G.H. Medical, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | Fresenius USA, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K903835 | ACETATE-FREE DIALYSLATE SOLUTION | Physio, Inc. | 1991-07-05 | Traditional | PDF ↗ |
| K910319 | ACID CONCENTRATE SOLUTIONS | Biopharm, Inc. | 1991-04-24 | Traditional | PDF ↗ |
| K910270 | PREMIXED DIALYSATE FOR HEMODIAFILTRATION | Baxter Healthcare Corp | 1991-04-18 | Traditional | PDF ↗ |
| K904946 | HAEMODIALYSIS CONCENTRATE | Bdh, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS | Medical Components, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K901472 | GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS | Granite Chemical Co., Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901471 | GC-1000 THROUGH GC-3005 ACID CONCENTRATE | Granite Chemical Co., Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901473 | GC-01 THROUGH GC-99 ACETATE CONCENTRATE | Granite Chemical Co., Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K893991 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | P & A Co. | 1990-01-11 | Traditional | PDF ↗ |
| K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB | Fresenius USA, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K895199 | BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE | Baxter Healthcare Corp | 1989-12-13 | Traditional | PDF ↗ |
| K891921 | BICARBONATE CONCENTRATE POWDER | Haemolyte, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K891159 | SODIUM BICARBONATE, U.S.P. | Williams Medical Co. | 1989-04-07 | Traditional | PDF ↗ |
| K884725 | BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS | Baxter Healthcare Corp | 1989-01-30 | Traditional | PDF ↗ |
| K883068 | HEMODIALYSIS CONCENTRATES | Dove Medical Supplies | 1988-12-22 | Traditional | PDF ↗ |
| K880102 | BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS | Baxter Healthcare Corp | 1988-05-26 | Traditional | PDF ↗ |
| K872857 | HOSPAL DIALYSATE FOR C.A.V.H.D. | Delmed, Inc. | 1987-10-05 | Traditional | PDF ↗ |
| K870979 | HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS | Inventory Supply Corp. | 1987-06-03 | Traditional | PDF ↗ |
| K865078 | POWDERED BICARBONATE CONCENTRATE | Bicarbolyte Corp. | 1987-03-27 | Traditional | PDF ↗ |
| K864265 | HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI | Dial Medical of Florida, Inc. | 1987-03-17 | Traditional | PDF ↗ |
Product code KPO · Class II · Gastroenterology, Urology. Data: openFDA.