| K252459 | fresenius medical care renal therapies group | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | February 10, 2026 |
| K253412 | outset medical | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | January 26, 2026 |
| K253518 | fresenius medical care renal therapies group | FX CorAL 40; FX CorAL 50 | December 18, 2025 |
| K243920 | medica usa | Purema H Hemoconcentrator - Pediatric | September 19, 2025 |
| K250508 | vantive us healthcare | AK 98 Dialysis Machine (955607) | August 1, 2025 |
| K243237 | fresenius medical care renal therapies group | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) | June 13, 2025 |
| K243505 | fresenius medical care renal therapies group | 5008X Hemodialysis System | May 30, 2025 |
| K242155 | nikkiso co | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | May 15, 2025 |
| K243264 | sorin group italia | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo | April 25, 2025 |
| K242053 | fresenius medical care renal therapies group | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | March 21, 2025 |
| K243874 | fresenius medical care renal therapies group | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX C | February 28, 2025 |
| K233798 | diality | Moda-flx Hemodialysis System and Cartridge | August 2, 2024 |
| K233557 | deka research and development | HemoCare Hemodialysis System | July 12, 2024 |
| K240394 | fresenius medical care renal therapies group | multiFlux 1000 (F00012408) | May 31, 2024 |
| K232776 | outset medical | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | May 3, 2024 |
| K232803 | nxstage medical | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | March 14, 2024 |
| K232171 | tecnoideal america | Purema® H Hemoconcentrator (EtO Sterilized) | February 7, 2024 |
| K231534 | fresenius medical care | 5008X Hemodialysis System | February 2, 2024 |
| K231125 | fresenius medical care renal therapies group | 2008T BlueStar Hemodialysis Machine | December 6, 2023 |
| K233335 | outset medical | Tablo® Hemodialysis System | December 5, 2023 |