FDA 510(k) Applications Submitted by FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K232926 |
09/20/2023 |
Novalung ultimate kit (US) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K250404 |
02/12/2025 |
stayòsafe« catheter extension set with Safe- Lock, 12 inch; stayòsafe« catheter extension set with Luer-Lock, 6 inch; stayòsafe« catheter extension set with Luer-Lock, 12 inch; stayòsafe« catheter extension set with Luer-Lock, 18 inch; stayòsafe« to Luer- |
Fresenius Medical Care Renal Therapies Group, LLC |
| K160749 |
03/18/2016 |
CRIT-LINE III Blood Chamber II |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K220281 |
02/01/2022 |
multiFiltratePRO System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K190459 |
02/26/2019 |
Hemoflow F3 and F4 Dialyzers |
Fresenius Medical Care Renal Therapies Group, LLC |
| K220721 |
03/14/2022 |
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 |
Fresenius Medical Care Renal Therapies Group, LLC |
| K150708 |
03/19/2015 |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K181108 |
04/27/2018 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K201207 |
05/05/2020 |
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 |
Fresenius Medical Care Renal Therapies Group, LLC |
| K141281 |
05/16/2014 |
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K191407 |
05/28/2019 |
Novalung System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K191474 |
06/04/2019 |
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K171652 |
06/05/2017 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K131908 |
06/26/2013 |
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K172238 |
07/26/2017 |
CAREline Airless Hemodialysis Blood Tubing Sets |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192017 |
07/29/2019 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K222318 |
08/02/2022 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K212522 |
08/11/2021 |
Lilliput APD System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192209 |
08/14/2019 |
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K212620 |
08/18/2021 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K182367 |
08/31/2018 |
DIASAFEplusUS |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192707 |
09/27/2019 |
Optiflux F180NR Dialyzer |
Fresenius Medical Care Renal Therapies Group, LLC |
| K162716 |
09/29/2016 |
bibag |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K203062 |
10/09/2020 |
Optiflux Series of Dialyzers F160NR, F180NR, F200NR |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173363 |
10/26/2017 |
Cycler Drain Bag Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173593 |
11/21/2017 |
stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173651 |
11/28/2017 |
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K153449 |
11/30/2015 |
2008K2 Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K173718 |
12/05/2017 |
Liberty Cycler Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K213992 |
12/21/2021 |
CombiSet Hemodialysis Blood Tubing Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173972 |
12/29/2017 |
2008T BlueStar Hemodialysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
| K141145 |
05/02/2014 |
LIBERTY PDX CYCLER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K222952 |
09/27/2022 |
2008T BlueStar Hemodailysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
| K231125 |
04/20/2023 |
2008T BlueStar Hemodialysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
| K232953 |
09/21/2023 |
AquaBplus; AquaB LITE |
Fresenius Medical Care Renal Therapies Group, LLC |
| K243505 |
11/12/2024 |
5008X Hemodialysis System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K243237 |
10/10/2024 |
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 |
| K240394 |
02/08/2024 |
multiFlux 1000 (F00012408) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K242053 |
07/12/2024 |
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K233159 |
09/27/2023 |
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 |
Fresenius Medical Care Renal Therapies Group, LLC |
| K243786 |
12/09/2024 |
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 (R |
Fresenius Medical Care Renal Therapies Group, LLC |
| K233950 |
12/14/2023 |
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K243874 |
12/17/2024 |
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 |
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