KPOFDA Class 2 · 21 CFR 876.5820
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device family · Gastroenterology, Urology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
123
Manufacturers
19
Flagged signals
35
Adverse-event reports
29,899
Code matrix
| FDA product code | KPO |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| GMDN | 35335 |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2024 | 16 | 91.0 | 1,337 |
| Death | 2017 | 12 | 31.0 | 321 |
| Death | 2011 | 9 | 13.1 | 90 |
| Death | 2016 | 5 | 12.9 | 44 |
| Death | 2015 | 6 | 12.9 | 55 |
| Death | 2012 | 2,960 | 12.1 | 30,011 |
| Death | 2011 | 5 | 10.7 | 35 |
| Death | 2014 | 7 | 10.2 | 50 |
| Death | 2011 | 2,223 | 9.1 | 15,916 |
| Death | 2016 | 6 | 8.7 | 34 |
| Death | 2014 | 4 | 8.6 | 20 |
| Death | 2019 | 3 | 7.7 | 12 |
| Death | 2010 | 1,605 | 6.5 | 7,513 |
| Death | 2010 | 3 | 6.4 | 9 |
| Death | 2013 | 3 | 6.4 | 9 |
| Death | 2010 | 4 | 5.8 | 12 |
| Death | 2009 | 1,318 | 5.4 | 4,671 |
| Death | 2012 | 1,164 | 4.7 | 3,423 |
| Death | 2011 | 3 | 4.4 | 5 |
| Death | 2014 | 3 | 4.4 | 5 |
| Death | 2012 | 3 | 4.4 | 5 |
| Death | 2008 | 1,053 | 4.3 | 2,644 |
| Death | 2011 | 978 | 4.0 | 2,174 |
| Death | 2010 | 973 | 3.9 | 2,144 |
| Death | 2009 | 867 | 3.5 | 1,563 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 29,899 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 10 | 2026 | — |
| Baxter Healthcare Corp | 6 | 2009 | — |
| NXSTAGE MEDICAL, INC. | 6 | 2024 | — |
| Fresenius Usa, Inc. | 4 | 1994 | — |
| DIASOL, INC. | 4 | 2014 | — |
| Fresenius Medical Care North America | 3 | 2013 | — |
| B.Braun Medical, Inc. | 3 | 2005 | — |
| Isopure, Corp. | 2 | 2020 | — |
| Erika, Inc. | 2 | 1982 | — |
| EDLAW PHARMACEUTICALS, INC. | 2 | 1981 | — |
| DIMESOL USA, LLC | 1 | 2018 | — |
| B. Braun Avitum AG | 1 | 2011 | — |
| Travenol Laboratories, S.A. | 1 | 1980 | — |
| Baxter Healthcare Corporation | 1 | 2017 | — |
| Mallinckrodt Critical Care | 1 | 1978 | — |
| Hospal Medical Corp. | 1 | 1986 | — |
| Medical Components, Inc. | 1 | 1991 | — |
| ROCKWELL MEDICAL | 1 | 2016 | — |
| Cobe Laboratories, Inc. | 1 | 1981 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2026-01-29
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, LLC510(k) · 2025-09-09
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, LLC510(k) · 2025-04-04
HemoCare Bicarbonate Concentrate Set (BCS) · Deka Research and Development510(k) · 2024-07-12
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2024-05-10
NxStage PureFlow Solution · Nxstage Medical, Inc.510(k) · 2024-01-18
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2023-12-01
Citric Complete Liquid Citric Acid Concentrate · Nipro Renal Solutions USA, Corp.510(k) · 2023-08-04
NIKKICART · Renal Care Dialysis Solutions, S.A. DE C.V.510(k) · 2023-03-03
Hemo-Lyte C Cartridge · Di-Chem, Inc.510(k) · 2022-08-12
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2022-05-12
HMB32 Dialysis Solution · Haemopharm Biofluids S.R.L.510(k) · 2021-07-23
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis · Nipro Renal Solutions USA, Corp.510(k) · 2020-11-25
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2020-05-08
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2020-04-24
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, LLC510(k) · 2020-02-24
Isopure Dry Acid Dissolution System · Isopure, Corp.510(k) · 2020-01-22
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, LLC510(k) · 2018-12-07
Citric Complete Dry Citric Acid (45X) · Dimesol USA, LLC510(k) · 2018-03-06
Citryte · Di-Chem, Inc.510(k) · 2017-10-13
bibag · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2017-05-18
PrismaSATE · Baxter Healthcare Corporation510(k) · 2017-01-06
Rockwell Medical CitraPure Acid Concetrate · Rockwell Medical510(k) · 2016-10-20
HMB32 · Haemopharm Biofluids S.R.L.510(k) · 2015-12-04
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X · Dialysis Medical Solutions, LLC510(k) · 2014-04-03
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.