# Fresenius Medical Care Renal Therapies Group, LLC

- Location (FDA's records): Waltham, MA
- FDA decisions: 53 (2013–2026): 53 510(k) clearances
- Product codes: KDI (20), KPO (10), FKX (6), FIP (4), KDJ (4), KOC (4), QJZ (2), FJI (1), DSB (1), FJK (1)
- 510(k) review time since 2016: median 189 days, against 199 for FDA's reviews in the same codes and years (12 of 31 faster)
- Predicates its devices cite: 75 (32 its own); citations of its devices by later devices: 42 (32 its own)
- Recalls linked to its devices: 57 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fresenius Medical Care North America: 10 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Fresenius Medical Care: 5 (https://510kreport.com/company/fresenius-medical-care)
- National Medical Care, Medical Products Div., Inc.: 4 (https://510kreport.com/company/national-medical-care-medical-products-div)
- Gambro Renal Products: 3 (https://510kreport.com/company/gambro-renal-products)
- Vivonic GmbH: 2 (https://510kreport.com/company/vivonic)
- Advanced Renal Technologies, Inc.: 2 (https://510kreport.com/company/advanced-renal-technologies)
- Fresenius Medical Care North America, Design Cente: 2 (https://510kreport.com/company/fresenius-medical-care-north-america-design-cente)
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)

## Firms that cite its devices most
- Fresenius Medical Care: 4 (https://510kreport.com/company/fresenius-medical-care)
- Byonyks Pvt, Ltd.: 1 (https://510kreport.com/company/byonyks-pvt)
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Nikkiso CO., LTD.: 1 (https://510kreport.com/company/nikkiso)
- Ningbo Tianyi Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/ningbo-tianyi-medical-appliance)

## Its most-cited devices
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (2023), cited by 3
- 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 (2020), cited by 3
- K181108: Fresenius Liberty Select Cycler (2018), cited by 3
- K231125: 2008T BlueStar Hemodialysis Machine (2023), cited by 3
- K173972: 2008T BlueStar Hemodialysis Machine (2018), cited by 2
- 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) (2025), cited by 2

## Recent decisions
- K261203: multiFiltratePRO System (Oct 19, 2026)
- K261267: Careflux H60;Careflux H70;Careflux V500 (Jul 24, 2026)
- K252377: NxStage System One with NxView (May 15, 2026)
- K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124) (Feb 10, 2026)
- K253462: NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (Jan 29, 2026)
- K253518: FX CorAL 40; FX CorAL 50 (Dec 18, 2025)
- K250634: BCM2-Body Composition Monitor (Nov 24, 2025)
- K250471: AquaC UNO H (Nov 14, 2025)

Source page: https://510kreport.com/company/fresenius-medical-care-renal-therapies-group