Medical Device Manufacturer · US , Waltham , MA

Fresenius Medical Care Renal Therapies Group, LLC

50 submissions · 50 cleared · Since 2013
50
Total
50
Cleared
0
Denied

Fresenius Medical Care Renal Therapies Group, LLC — FDA 510(k) Submissions

Fresenius Medical Care Renal Therapies Group, LLC has submitted 50 FDA 510(k) premarket notifications since 2013, of which 50 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Dialysate Concentrate For Hemodialysis (liquid Or Powder), System, Peritoneal, Automatic Delivery, Subsystem, Water Purification, Accessories, Blood Circuit, Hemodialysis . Use the specialty filter in the sidebar to narrow results.

50 devices
1–25 of 50
multiFlux 130 (F00013123); multiFlux 160 (F00013124)
K252459 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 2026 189d
NaturaLyte? Dry Bicarbonate Concentrate (08-4112-2)
K253462 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jan 2026 114d
FX CorAL 40; FX CorAL 50
K253518 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2025 36d
BCM2-Body Composition Monitor
K250634 · DSB Plethysmograph, Impedance · Gastroenterology & Urology
Nov 2025 266d
AquaC UNO H
K250471 · FIP Subsystem, Water... · Gastroenterology & Urology
Nov 2025 269d
DIASAFEplusUS (F00013010)
K251851 · FIP Subsystem, Water... · Gastroenterology & Urology
Oct 2025 115d
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)
K252180 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Sep 2025 60d
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)
K243237 · KDI Dialyzer, High... · Gastroenterology & Urology
Jun 2025 246d
5008X Hemodialysis System
K243505 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2025 199d
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)
K243786 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Apr 2025 116d
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
K250404 · KDJ Set, Administration, For... · Gastroenterology & Urology
Apr 2025 50d
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
K242053 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2025 252d
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)
K243874 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 2025 73d
AquaBplus; AquaB LITE
K232953 · FIP Subsystem, Water... · Gastroenterology & Urology
Jun 2024 266d
multiFlux 1000 (F00012408)
K240394 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2024 113d
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
K233950 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
May 2024 148d
Novalung ultimate kit (US)
K232926 · QJZ Extracorporeal System For... · Cardiovascular
Apr 2024 208d
2008T BlueStar Hemodialysis Machine
K231125 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2023 230d
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
K233159 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Dec 2023 65d
CombiSet Hemodialysis Blood Tubing Set
K213992 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
May 2023 526d
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
K220721 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2023 423d
multiFiltratePRO System
K220281 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2022 318d
Fresenius Liberty Select Cycler
K222318 · FKX System, Peritoneal,... · Gastroenterology & Urology
Oct 2022 90d
2008T BlueStar Hemodailysis Machine
K222952 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2022 30d
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
May 2022 267d
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