| 345254 | 1052455784 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | 2026-02-10 |
| 345254 | 1916081967 | 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) | KPO | 2025-09-09 |
| 345254 | 2012938936 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | KDI | 2025-02-28 |
| 345254 | 2042201781 | K243505 | 5008X Hemodialysis System | KDI | 2025-05-30 |
| 345254 | 1787097501 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | KPO | 2023-12-01 |
| 345254 | 1180042780 | K231534 | 5008X Hemodialysis System | KDI | 2024-02-02 |
| 345254 | 1865982715 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | KDI | 2023-05-11 |