Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US
Fresenius Medical Care Renal Therapies Group, LLC appears in FDA device records in Waltham, MA. FDA records list 95 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 204 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Fresenius Medical Care Renal Therapies Group, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Fresenius Medical Care Holdings, Inc.enforcement report, recall
- Fresenius Medical Care-North America510(k), recall
510(k) clearance history
Showing 50 of 95FDA records hold 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC between 1998 and 2026. The busiest year on record is 2025, with 12. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 7 |
| 2001 | 4 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 7 |
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 12 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500 | KDI | Substantially Equivalent | |
| K252377 | NxStage System One with NxView | KDI | Substantially Equivalent | |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | Substantially Equivalent | |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | Substantially Equivalent | |
| K253518 | FX CorAL 40; FX CorAL 50 | KDI | Substantially Equivalent | |
| K250634 | BCM2-Body Composition Monitor | DSB | Substantially Equivalent | |
| K250471 | AquaC UNO H | FIP | Substantially Equivalent | |
| K251851 | DIASAFEplusUS (F00013010) | FIP | Substantially Equivalent | |
| K252181 | AquaA | FIP | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K243505 | 5008X Hemodialysis System | KDI | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | KDI | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K232953 | AquaBplus; AquaB LITE | FIP | Substantially Equivalent | |
| K240394 | multiFlux 1000 (F00012408) | KDI | Substantially Equivalent | |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | KPO | Substantially Equivalent | |
| K232926 | Novalung ultimate kit (US) | QJZ | Substantially Equivalent | |
| K231125 | 2008T BlueStar Hemodialysis Machine | KDI | Substantially Equivalent | |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | KPO | Substantially Equivalent | |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | FJK | Substantially Equivalent | |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | KDI | Substantially Equivalent | |
| K220281 | multiFiltratePRO System | KDI | Substantially Equivalent | |
| K222318 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | |
| K222952 | 2008T BlueStar Hemodailysis Machine | KDI | Substantially Equivalent | |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | |
| K212522 | Lilliput APD System | FKX | Substantially Equivalent | |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | KDI | Substantially Equivalent | |
| K192707 | Optiflux F180NR Dialyzer | KDI | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | Substantially Equivalent | |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | |
| K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | Substantially Equivalent | |
| K191407 | Novalung System | QJZ | Substantially Equivalent | |
| K190459 | Hemoflow F3 and F4 Dialyzers | FJI | Substantially Equivalent | |
| K182367 | DIASAFEplusUS | FIP | Substantially Equivalent | |
| K181108 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | |
| K173593 | 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 | Substantially Equivalent | |
| K173972 | 2008T BlueStar Hemodialysis Machine | KDI | Substantially Equivalent | |
| K173718 | Liberty Cycler Set | FKX | Substantially Equivalent | |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | KDJ | Substantially Equivalent | |
| K173363 | Cycler Drain Bag Set | KDJ | Substantially Equivalent | |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | KOC | Substantially Equivalent | |
| K171652 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | |
| K162716 | bibag | KPO | Substantially Equivalent | |
| K162488 | Optiflux dialyzer | KDI | Substantially Equivalent | |
| K153449 | 2008K2 Hemodialysis Machine | KDI | Substantially Equivalent | |
| K160749 | CRIT-LINE III Blood Chamber II | KOC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1225714 | 3001451489 | Fresenius Medical Care Renal Therapies Group, LLC | 920 WINTER STREET, Waltham, MA 02451 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- NIIDisinfectant, Dialysate Delivery System
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- ONWHemodialysis System For Home Use
- MSEHemodialyzer, Re-Use, Low Flux
- DSBPlethysmograph, Impedance
- FIBProtector, Transducer, Dialysis
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FIPSubsystem, Water Purification
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal
- FKPSystem, Dialysate Delivery, Single Patient
- FKXSystem, Peritoneal, Automatic Delivery
Recall records
Showing 25 of 204| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3087-2026 | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | Class II | Open, Classified | |
| Z-3086-2026 | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | Class II | Open, Classified | |
| Z-3085-2026 | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | Class II | Open, Classified | |
| Z-3084-2026 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | Class II | Open, Classified | |
| Z-3017-2026 | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines. | Class II | Open, Classified | |
| Z-2321-2026 | Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor. | Class II | Open, Classified | |
| Z-2702-2026 | 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8. | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. | Class II | Open, Classified | |
| Z-2401-2026 | Bicarby Dialysate; Model number: RFP-400-G; | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result. | Class II | Open, Classified | |
| Z-0936-2026 | 5008X CAREsystem +CLiC +CDX; | Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled. | Class II | Open, Classified | |
| Z-0041-2026 | Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM | To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap. | Class II | Open, Classified | |
| Z-1992-2025 | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2. | Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration. | Class II | Open, Classified | |
| Z-0801-2025 | Dialyzer Optiflux 160NRe | Potential for internal blood leaks due to cracked polyurethane | Class II | Open, Classified | |
| Z-3124-2024 | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130 | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff. | Class II | Open, Classified | |
| Z-2347-2024 | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2346-2024 | RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2345-2024 | RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2344-2024 | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2343-2024 | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2342-2024 | 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2341-2024 | 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2340-2024 | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-2141-2024 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1 | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply. | Class II | Open, Classified | |
| Z-1870-2024 | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-1869-2024 | 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified | |
| Z-1868-2024 | 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain