| K253462 | fresenius medical care renal therapies group | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | January 29, 2026 |
| K252180 | fresenius medical care renal therapies group | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi | September 9, 2025 |
| K243786 | fresenius medical care renal therapies group | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi | April 4, 2025 |
| K240920 | deka research and development | HemoCare Bicarbonate Concentrate Set (BCS) | July 12, 2024 |
| K233950 | fresenius medical care renal therapies group | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu | May 10, 2024 |
| K233213 | nxstage medical | NxStage PureFlow Solution | January 18, 2024 |
| K233159 | fresenius medical care renal therapies group | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 | December 1, 2023 |
| K223431 | nipro renal solutions usa | Citric Complete Liquid Citric Acid Concentrate | August 4, 2023 |
| K221652 | renal care dialysis solutions, s.a. de c.v | NIKKICART | March 3, 2023 |
| K202508 | di-chem | Hemo-Lyte C Cartridge | August 12, 2022 |
| K212620 | fresenius medical care renal therapies group | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | May 12, 2022 |
| K212052 | haemopharm biofluids | HMB32 Dialysis Solution | July 23, 2021 |
| K193155 | nipro renal solutions usa | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | November 25, 2020 |
| K192209 | fresenius medical care renal therapies group | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | May 8, 2020 |
| K192017 | fresenius medical care renal therapies group | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | April 24, 2020 |
| K191474 | fresenius medical care renal therapies group | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate C | February 24, 2020 |
| K191093 | isopure | Isopure Dry Acid Dissolution System | January 22, 2020 |
| K180679 | global scientific technologies | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiC | December 7, 2018 |
| K171750 | dimesol usa | Citric Complete Dry Citric Acid (45X) | March 6, 2018 |
| K171015 | di-chem | Citryte | October 13, 2017 |