Company · US
Fresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (8 in 12 months)
34recalls (9 in 12 months)
34recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 32 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 22 |
| FKX | System, Peritoneal, Automatic Delivery | 9 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 9 |
| FIP | Subsystem, Water Purification | 4 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 |
| QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | 2 |
| DSB | Plethysmograph, Impedance | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2026 | K261203 | multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jul 24, 2026 | K261267 | Careflux H60;Careflux H70;Careflux V500 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 15, 2026 | K252377 | NxStage System One with NxView Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Feb 10, 2026 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jan 29, 2026 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Dec 18, 2025 | K253518 | FX CorAL 40; FX CorAL 50 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Nov 24, 2025 | K250634 | BCM2-Body Composition Monitor Fresenius Medical Care Renal Therapies Group, LLC | DSB |
| Nov 14, 2025 | K250471 | AquaC UNO H Fresenius Medical Care Renal Therapies Group, LLC | FIP |
| Oct 9, 2025 | K251851 | DIASAFEplusUS (F00013010) Fresenius Medical Care Renal Therapies Group, LLC | FIP |
| Sep 9, 2025 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bic Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Jun 13, 2025 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 30, 2025 | K243505 | 5008X Hemodialysis System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Apr 4, 2025 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bic Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 3, 2025 | K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; st Fresenius Medical Care Renal Therapies Group, LLC | KDJ |
| Mar 21, 2025 | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Feb 28, 2025 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F000 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jun 13, 2024 | K232953 | AquaBplus; AquaB LITE Fresenius Medical Care Renal Therapies Group, LLC | FIP |
| May 31, 2024 | K240394 | multiFlux 1000 (F00012408) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 10, 2024 | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 15, 2024 | K232926 | Novalung ultimate kit (US) Fresenius Medical Care Renal Therapies Group, LLC | QJZ |
| Dec 6, 2023 | K231125 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Dec 1, 2023 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| May 31, 2023 | K213992 | CombiSet Hemodialysis Blood Tubing Set Fresenius Medical Care Renal Therapies Group, LLC | FJK |
| May 11, 2023 | K220721 | 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 | KDI |
| Dec 16, 2022 | K220281 | multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Oct 31, 2022 | K222318 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Oct 27, 2022 | K222952 | 2008T BlueStar Hemodailysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 12, 2022 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 15, 2022 | K212522 | Lilliput APD System Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Dec 28, 2020 | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Sep 21, 2020 | K192707 | Optiflux F180NR Dialyzer Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Sep 18, 2020 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| May 8, 2020 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 24, 2020 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Feb 24, 2020 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry B Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Feb 21, 2020 | K191407 | Novalung System Fresenius Medical Care Renal Therapies Group, LLC | QJZ |
| Aug 23, 2019 | K190459 | Hemoflow F3 and F4 Dialyzers Fresenius Medical Care Renal Therapies Group, LLC | FJI |
| Jan 10, 2019 | K182367 | DIASAFEplusUS Fresenius Medical Care Renal Therapies Group, LLC | FIP |
| May 24, 2018 | K181108 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| May 21, 2018 | K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, stay Fresenius Medical Care Renal Therapies Group, LLC | KDJ |
| May 10, 2018 | K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 1, 2018 | K173718 | Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Feb 14, 2018 | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set Fresenius Medical Care Renal Therapies Group, LLC | KDJ |
| Jan 24, 2018 | K173363 | Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC | KDJ |
| Dec 14, 2017 | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Sep 15, 2017 | K171652 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| May 18, 2017 | K162716 | bibag Fresenius Medical Care Renal Therapies Group, LLC | KPO |
| Apr 26, 2016 | K153449 | 2008K2 Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Apr 15, 2016 | K160749 | CRIT-LINE III Blood Chamber II Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Dec 10, 2015 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Fresenius Medical Care Renal Therapies Group, LLC CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;
Model Number: 03-2522-1; Open, Classified |
FJK | K213992 |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | K192017 K212620 |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Open, Classified |
KPO | K192017 K212620 |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | K192209 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with Twister Blood
Tubing Set
Part Number 03-5350-8 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with CLiC Blood
Tubing Set
Part number 03-5300-3C Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF Standard Blood
Tubing Set
Part Number 03-5300-3 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X Standard HD Pre-Flush
Standard Blood Tubing Set
Part Number 03-5110-6 Open, Classified |
KOC | K243505 |
| Aug 26, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. Open, Classified |
KDI | K243237 |
| May 29, 2019 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows:
(1) LIBERTY Line Cycler Set with Sta Terminated |
FKX | K173718 |
| Apr 3, 2019 | Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Machine Software v.2.72-Hemodialysis machine
Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare fa Terminated |
KDI | K173972 |
| Nov 5, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E Terminated |
KDI | K152367 K162488 |
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OFD3251-3B for hemodialysis Terminated |
KPO | K030497 |
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2251-3B for hemodialysis Terminated |
KPO | K030497 |
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2201-3B for hemodialysis Terminated |
KPO | K030497 |
| Jul 13, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138
Product Usage:
Indicated for acute and chronic dialysis therapy. Terminated |
KDI | K173972 |
| Jul 13, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138
Product Usage:
Indicated for acute and chronic dialysis therapy. Terminated |
KDI | K173972 |
| May 2, 2018 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1
Product Usage:
This concentrate is formulated to be used in conjunction with Fresenius Renal Technolog Terminated |
KPO | K070177 |
| Mar 20, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861 Terminated |
KDI | K153449 |
| Feb 20, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008T, Hemodialysis Delivery System
Product Indicated for acute and chronic dialysis therapy. Terminated |
KDI | K080964 K113427 +3 |
| Jan 24, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343
Product Usage:
The device is indicated for acute and chronic peritoneal dialysis. Terminated |
FKX | K171652 |
| Sep 29, 2017 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0
3.43 liter bottle
This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concen Terminated |
KPO | K070177 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K@home Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K2 Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008T Series Hemodialysis System Terminated |
KDI | K150708 |
| May 24, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Crit Line in a Clip (CLiC). CliC P/N: CL 10041001
CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysi Terminated |
KOC | K121599 |
| Apr 5, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:
Models:
Fresenius 2008K and 2008K2 Dialysate Delivery System
Fresenius 2008K@home Hemodialysis Machine with b Terminated |
KDI | K080964 K113427 +3 |
| Apr 5, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Hemoflow F3 Dialyzer
Part Number: 0520165A
Indicated for Acute and Chronic Hemodialysis Terminated |
FJI | K874872 |
| Feb 25, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Naturalyte Liquid Acid Concentrate
Catalog Number: 08-2301-3
Intended Use: Acid Concentrate for Bicarbonate Dialysis Terminated |
KPO | K070177 |
| Jan 27, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Cycler-Peritoneal Dialysis Cycler
Model: 180111 and RTLR180111 Terminated |
FKX | K043363 K123630 |
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | K131611 |
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | K131611 |
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | K911459 |