KPO
- Product code
- KPO
- Device name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 124 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260799 | 2026-08-19 | Nipro Technical Solutions, Incoporated | Nipro Dry Acid Concentrate Mixer | |
| K253462 | 2026-01-29 | Fresenius Medical Care Renal Therapies… | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | |
| K252180 | 2025-09-09 | Fresenius Medical Care Renal Therapies… | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialy… | |
| K243786 | 2025-04-04 | Fresenius Medical Care Renal Therapies… | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialy… | |
| K240920 | 2024-07-12 | Deka Research and Development | HemoCare Bicarbonate Concentrate Set (BCS) | |
| K233950 | 2024-05-10 | Fresenius Medical Care Renal Therapies… | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); … | |
| K233213 | 2024-01-18 | Nxstage Medical, Inc. | NxStage PureFlow Solution | FDA |
| K233159 | 2023-12-01 | Fresenius Medical Care Renal Therapies… | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 4… |
Official FDA classification page: KPO
Classification and pathway per current FDA publications. Data from openFDA (CC0).