Chrysalis Intelligence · Sponsors · Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC

Waltham, MA, US · 35 510(k) clearances

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Total clearances
35
2020-02-21 → 2026-07-24
Last 12 months
9
Product codes
9
Most recent
2026-07-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II Gastroenterology, Urology 15 2026-07-24
KPO — — — 9 2026-01-29
FIP — — — 3 2025-11-14
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Class II Cardiovascular 2 2024-04-15
FKX System, Peritoneal, Automatic Delivery Class II Gastroenterology, Urology 2 2022-10-31
DSB — — — 1 2025-11-24
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Class II Gastroenterology, Urology 1 2025-04-03
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Class II Gastroenterology, Urology 1 2023-05-31
KOC Accessories, Blood Circuit, Hemodialysis Class II Gastroenterology, Urology 1 2020-09-18
Filings

All 510(k) clearances (35)

Date K-number Device Code Class Specialty
2026-07-24 K261267 Careflux H60;Careflux H70;Careflux V500 KDI Class II Gastroenterology, Urology
2026-05-15 K252377 NxStage System One with NxView KDI Class II Gastroenterology, Urology
2026-02-10 K252459 multiFlux 130 (F00013123); multiFlux 160 (F00013124) KDI Class II Gastroenterology, Urology
2026-01-29 K253462 NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) KPO — —
2025-12-18 K253518 FX CorAL 40; FX CorAL 50 KDI Class II Gastroenterology, Urology
2025-11-24 K250634 BCM2-Body Composition Monitor DSB — —
2025-11-14 K250471 AquaC UNO H FIP — —
2025-10-09 K251851 DIASAFEplusUS (F00013010) FIP — —
2025-09-09 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 — —
2025-06-13 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 Class II Gastroenterology, Urology
2025-05-30 K243505 5008X Hemodialysis System KDI Class II Gastroenterology, Urology
2025-04-04 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 — —
2025-04-03 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 Class II Gastroenterology, Urology
2025-03-21 K242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) KDI Class II Gastroenterology, Urology
2025-02-28 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 Class II Gastroenterology, Urology
2024-06-13 K232953 AquaBplus; AquaB LITE FIP — —
2024-05-31 K240394 multiFlux 1000 (F00012408) KDI Class II Gastroenterology, Urology
2024-05-10 K233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) KPO — —
2024-04-15 K232926 Novalung ultimate kit (US) QJZ Class II Cardiovascular
2023-12-06 K231125 2008T BlueStar Hemodialysis Machine KDI Class II Gastroenterology, Urology
2023-12-01 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 KPO — —
2023-05-31 K213992 CombiSet Hemodialysis Blood Tubing Set FJK Class II Gastroenterology, Urology
2023-05-11 K220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 KDI Class II Gastroenterology, Urology
2022-12-16 K220281 multiFiltratePRO System KDI Class II Gastroenterology, Urology
2022-10-31 K222318 Fresenius Liberty Select Cycler FKX Class II Gastroenterology, Urology
2022-10-27 K222952 2008T BlueStar Hemodailysis Machine KDI Class II Gastroenterology, Urology
2022-05-12 K212620 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate KPO — —
2022-04-15 K212522 Lilliput APD System FKX Class II Gastroenterology, Urology
2020-12-28 K203062 Optiflux Series of Dialyzers F160NR, F180NR, F200NR KDI Class II Gastroenterology, Urology
2020-09-21 K192707 Optiflux F180NR Dialyzer KDI Class II Gastroenterology, Urology
2020-09-18 K201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line KOC Class II Gastroenterology, Urology
2020-05-08 K192209 Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate KPO — —
2020-04-24 K192017 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate KPO — —
2020-02-24 K191474 NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) KPO — —
2020-02-21 K191407 Novalung System QJZ Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence