| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026-01-26 |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | 2025-09-19 |
| K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025-08-01 |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. | 2025-05-15 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Sorin Group Italia S.R.L. | 2025-04-25 |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 |
| 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) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 |
| K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024-08-02 |
| K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024-07-12 |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 |