Fresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) & PMA Approved Devices — 48 products
Total Devices48
Categories10
Latest FDA decision2026-07-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261267 | Careflux H60;Careflux H70;Careflux V500 | KDI | 2026-07-24 | View |
| 510(k) | K252377 | NxStage System One with NxView | KDI | 2026-05-15 | View |
| 510(k) | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | 2026-02-10 | View |
| 510(k) | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | 2026-01-29 | View |
| 510(k) | K253518 | FX CorAL 40; FX CorAL 50 | KDI | 2025-12-18 | View |
| 510(k) | K250634 | BCM2-Body Composition Monitor | DSB | 2025-11-24 | View |
| 510(k) | K250471 | AquaC UNO H | FIP | 2025-11-14 | View |
| 510(k) | K251851 | DIASAFEplusUS (F00013010) | FIP | 2025-10-09 | View |
| 510(k) | 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 | View |
| 510(k) | 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) | KDI | 2025-06-13 | View |
| 510(k) | K243505 | 5008X Hemodialysis System | KDI | 2025-05-30 | View |
| 510(k) | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | KPO | 2025-04-04 | View |
| 510(k) | K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch | KDJ | 2025-04-03 | View |
| 510(k) | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | KDI | 2025-03-21 | View |
| 510(k) | 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 | View |
| 510(k) | K232953 | AquaBplus; AquaB LITE | FIP | 2024-06-13 | View |
| 510(k) | K240394 | multiFlux 1000 (F00012408) | KDI | 2024-05-31 | View |
| 510(k) | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | KPO | 2024-05-10 | View |
| 510(k) | K232926 | Novalung ultimate kit (US) | QJZ | 2024-04-15 | View |
| 510(k) | K231125 | 2008T BlueStar Hemodialysis Machine | KDI | 2023-12-06 | View |
No matching devices.
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