KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Class II
FDA product code KPO covers "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPO
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| 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 |