KPO · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Gastroenterology, Urology · 21 CFR 876.5820 · Class 2
Overview
| Product Code | KPO |
|---|---|
| Device Name | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| Regulation | 21 CFR 876.5820 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Classification Rationale
(1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (123)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | Jan 29, 2026 | SESE |
| 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 | Sep 9, 2025 | SESE |
| 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 | Apr 4, 2025 | SESE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | Jul 12, 2024 | SESE |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | May 10, 2024 | SESE |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | Jan 18, 2024 | SESE |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | Dec 1, 2023 | SESE |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | Aug 4, 2023 | SESE |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | Mar 3, 2023 | SESE |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | Aug 12, 2022 | SESE |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | May 12, 2022 | SESE |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | Jul 23, 2021 | SESE |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | Nov 25, 2020 | SESE |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | May 8, 2020 | SESE |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | Apr 24, 2020 | SESE |
| 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 | Feb 24, 2020 | SESE |
| K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | Jan 22, 2020 | SESE |
| 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 | Dec 7, 2018 | SESE |
| K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | Mar 6, 2018 | SESE |
| K171015 | Citryte | Di-Chem, Inc. | Oct 13, 2017 | SESE |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | May 18, 2017 | SESE |
| K162887 | PrismaSATE | Baxter Healthcare Corporation | Jan 6, 2017 | SESE |
| K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | Oct 20, 2016 | SESE |
| K150966 | HMB32 | Haemopharm Biofluids S.R.L. | Dec 4, 2015 | SESE |
| K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X | Dialysis Medical Solutions, LLC | Apr 3, 2014 | SESE |
| K130511 | CITRISOL ACID CONCENTRATE | Diasol, Inc. | Feb 10, 2014 | SESE |
| K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS | Fresenius Medical Care North America | Aug 29, 2013 | SESE |
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY | Gambro Renal Products | May 25, 2012 | SESE |
| K120005 | ACDS | Isopure, Corp. | Mar 29, 2012 | SESE |
| K102194 | SOLCART B | B. Braun Avitum AG | Apr 25, 2011 | SESE |
| K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A | Baxter Healthcare Corp | Aug 7, 2009 | SESE |
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | Gambro Renal Products | Feb 4, 2008 | SESE |
| K072760 | SOLCART B | B. Braun Medizintechnologie GmbH | Jan 29, 2008 | SESE |
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB | Fresenius Medical Care North America | Jun 15, 2007 | SESE |
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | Fresenius Medical Care North America | Mar 29, 2007 | SESE |
| K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | Rockwell Medical Technologies, Inc. | Nov 17, 2006 | SESE |
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | Dec 22, 2005 | SESE |
| K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE | B.Braun Medical, Inc. | Nov 9, 2005 | SESE |
| K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | Gambro Renal Products | Nov 2, 2005 | SESE |
| K050827 | NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) | Dialysis Solutions, Inc. | Aug 22, 2005 | SESE |
| K042045 | NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | Aug 27, 2004 | SESE |
| K041683 | B. BRAUN BICARBONATE DIALYSATE | B.Braun Medical, Inc. | Aug 27, 2004 | SESE |
| K041428 | ACCUSOL DIALYSIS SOLUTION | Baxter Healthcare Corp | Aug 27, 2004 | SESE |
| K034066 | B.BRAUN PREMIXED DIALYSATE | B.Braun Medical, Inc. | Mar 3, 2004 | SESE |
| K033386 | NXSTAGE PUREFLOW SOLUTION | Nxstage Medical, Inc. | Nov 26, 2003 | SESE |
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | Fresenius Medical Care | May 20, 2003 | SESE |
| K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE | Rockwell Medical Technologies, Inc. | Feb 28, 2003 | SESE |
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON | Rockwell Medical Technologies, Inc. | Jan 3, 2003 | SESE |
| K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | Rockwell Medical Technologies, Inc. | Dec 23, 2002 | SESE |
| K022913 | NXSTAGE PREMIXED DIALYSATE | Nxstage Medical, Inc. | Oct 21, 2002 | SESE |
| K020231 | DIASOL-ADDITIVES | Diasol, Inc. | Oct 21, 2002 | SESE |
| K020230 | DIASOL-BICARB | Diasol, Inc. | Apr 23, 2002 | SESE |
| K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 | Nxstage Medical, Inc. | Feb 4, 2002 | SESE |
| K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Di-Chem, Inc. | Jan 18, 2002 | SESE |
| K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | Di-Chem, Inc. | Jan 18, 2002 | SESE |
| K013448 | PRISMASATE | Gambro Renal Products | Jan 15, 2002 | SESE |
| K013724 | BICART | Gambro Renal Products | Jan 8, 2002 | SESE |
| K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | Gambro Renal Products | Aug 2, 2001 | SESE |
| K010760 | ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS | Advanced Renal Technologies, Inc. | Jun 11, 2001 | SESE |
| K001059 | NORMOCARB STERILE BICARBONATE RENAL DIALYSIS | Novex Pharma | Jun 30, 2000 | SESE |
| K000792 | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX | Advanced Renal Technologies, Inc. | Jun 8, 2000 | SESE |
| K993212 | DRYASOL ACID CONCENTRATE MIX | Diasol, Inc. | Oct 22, 1999 | SESE |
| K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE | Rockwell Medical Technologies, Inc. | Aug 5, 1999 | SESE |
| K990507 | ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER | Althin Biopharm, Inc. | May 7, 1999 | SESE |
| K990010 | ALTHIN MEDICAL AB ALTRACART II | Althin Medical AB | Apr 15, 1999 | SESE |
| K982813 | NATURALYTE, MODEL # 08-4004-1 | Kaybath, Inc. | Nov 6, 1998 | SESE |
| K982378 | HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE | Solution Technologies | Aug 26, 1998 | SESE |
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | International Medical Products, Inc. | Jun 16, 1998 | SESE |
| K980659 | DRYALYSATE CONCENTRATE | Advanced Renal Technologies, Inc. | Jun 11, 1998 | SESE |
| K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL | Solution Technologies | May 26, 1998 | SESE |
| K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | International Medical Products, Inc. | Oct 30, 1997 | SESE |
| K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | International Medical Products, Inc. | Jun 16, 1997 | SESE |
| K954527 | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | Rockwell Medical Supply | Mar 1, 1996 | SESE |
| K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE | Fresenius USA, Inc. | Oct 17, 1994 | SESE |
| K941958 | WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE | Western Dialysis Supplies , Ltd. | Sep 30, 1994 | SESE |
| K922990 | HEMODIALYSIS BATH | Medi-Tech, Inc. | Sep 12, 1994 | SESE |
| K922005 | GRANULYTE DIALYSATE CONCENTRATE | Fresenius USA, Inc. | Mar 30, 1994 | SESE |
| K940601 | GAMBRO BICART 720G | C.G.H. Medical, Inc. | Mar 22, 1994 | SESE |
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | Fresenius USA, Inc. | Jul 17, 1991 | SESE |
| K903835 | ACETATE-FREE DIALYSLATE SOLUTION | Physio, Inc. | Jul 5, 1991 | SESE |
| K910319 | ACID CONCENTRATE SOLUTIONS | Biopharm, Inc. | Apr 24, 1991 | SESE |
| K910270 | PREMIXED DIALYSATE FOR HEMODIAFILTRATION | Baxter Healthcare Corp | Apr 18, 1991 | SESE |
| K904946 | HAEMODIALYSIS CONCENTRATE | Bdh, Inc. | Apr 9, 1991 | SESE |
| K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS | Medical Components, Inc. | Mar 15, 1991 | SESE |
| K901473 | GC-01 THROUGH GC-99 ACETATE CONCENTRATE | Granite Chemical Co., Inc. | Jul 27, 1990 | SESE |
| K901472 | GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS | Granite Chemical Co., Inc. | Jul 27, 1990 | SESE |
| K901471 | GC-1000 THROUGH GC-3005 ACID CONCENTRATE | Granite Chemical Co., Inc. | Jul 27, 1990 | SESE |
| K893991 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | P & A Co. | Jan 11, 1990 | SESE |
| K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB | Fresenius USA, Inc. | Dec 27, 1989 | SESE |
| K895199 | BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE | Baxter Healthcare Corp | Dec 13, 1989 | SESE |
| K891921 | BICARBONATE CONCENTRATE POWDER | Haemolyte, Inc. | Apr 17, 1989 | SESE |
| K891159 | SODIUM BICARBONATE, U.S.P. | Williams Medical Co. | Apr 7, 1989 | SESE |
| K884725 | BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS | Baxter Healthcare Corp | Jan 30, 1989 | SESE |
| K883068 | HEMODIALYSIS CONCENTRATES | Dove Medical Supplies | Dec 22, 1988 | SESE |
| K880102 | BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS | Baxter Healthcare Corp | May 26, 1988 | SESE |
| K872857 | HOSPAL DIALYSATE FOR C.A.V.H.D. | Delmed, Inc. | Oct 5, 1987 | SESE |
| K870979 | HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS | Inventory Supply Corp. | Jun 3, 1987 | SESE |
| K865078 | POWDERED BICARBONATE CONCENTRATE | Bicarbolyte Corp. | Mar 27, 1987 | SESE |
| K864265 | HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI | Dial Medical of Florida, Inc. | Mar 17, 1987 | SESE |
| K864942 | BICARBONATE MIXING SYSTEM | Morris Tool , Ltd. | Mar 10, 1987 | SESE |
| K863631 | SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS | American Healthcare Corp. | Oct 16, 1986 | SESE |
| K861156 | HOSPAL DIALYSATE FOR CAVHD | Hospal Medical Corp. | Sep 23, 1986 | SESE |
| K852955 | HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD | Renalchem, Inc. | Feb 5, 1986 | SESE |
| K854206 | ULTRACLONE 05-100 GUINEA PIG RBC | Earl-Clay Laboratories, Inc. | Oct 31, 1985 | SESE |
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES | Dana Laboratories | Jun 12, 1985 | SESE |
| K843866 | HEMODIALYSATE SOLUTIONS | Bicarbolyte Corp. | Jan 9, 1985 | SESE |
| K834538 | LAS-2 ALIGNMENT SYSTEM | Therados, Inc. | Feb 21, 1984 | SESE |
| K832866 | HEMO-DIAL | Cmi Pharmaceuticals, Inc. | Nov 3, 1983 | SESE |
| K823779 | DIALYTE | Renal Dynamics, Inc. | Jan 17, 1983 | SESE |
| K823103 | DIALYSATE ADDITIVES-POWDER/LIQUID | Di-Chem, Inc. | Nov 17, 1982 | SESE |
| K821304 | CENTRALYTE BICARBONATE CONCENTRATE | Erika, Inc. | May 18, 1982 | SESE |
| K820150 | K-AID | Sytek Laboratories | Jan 29, 1982 | SESE |
| K813586 | DIALYSIS CONCENTRATE | Diversified Medical Services | Jan 29, 1982 | SESE |
| K813388 | HEMODIALYSATE | Edlaw Pharmaceuticals, Inc. | Dec 31, 1981 | SESE |
| K811706 | LACTIC ACID DIALYSATE ADDITIVE | Edlaw Pharmaceuticals, Inc. | Sep 24, 1981 | SESE |
| K810925 | NATURALYTE BICARBONATE DIALYSATE CONCEN. | Erika, Inc. | Apr 23, 1981 | SESE |
| K810527 | CHEM-DIALYTE CONCENTRATES | Luchem Pharmaceuticals, Inc. | Apr 23, 1981 | SESE |
| K810280 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS | Cobe Laboratories, Inc. | Feb 19, 1981 | SESE |
| K800624 | LOW-ACETATE HEMODIALYSIS BATH CONCENTR. | Travenol Laboratories, S.A. | Jul 14, 1980 | SESE |
| K792513 | HEMODIALYSIS CONCENTRATE SOLUTION | Mid Atlantic Nephrology Center | Apr 8, 1980 | SESE |
| K792213 | RENAL SYSTEMS HEMODIALYSIS CONCENTRATE | Renal Systems, Inc. | Jan 4, 1980 | SESE |
| K781967 | HEMODIALYSIS CONCENTRATE, SODIU | Renal Systems, Inc. | Dec 7, 1978 | SESE |
| K780353 | DRI-LYTE | Mallinckrodt Critical Care | Apr 5, 1978 | SESE |
Top Applicants
- Fresenius Medical Care Renal Therapies Group, LLC — 10 clearances
- Nxstage Medical, Inc. — 6 clearances
- Gambro Renal Products — 6 clearances
- Baxter Healthcare Corp — 6 clearances
- Rockwell Medical Technologies, Inc. — 5 clearances
