# Fresenius Medical Care North America, Design Cente

- Location (FDA's records): Waltham, MA
- FDA decisions: 5 (2010–2013): 5 510(k) clearances
- Product codes: KDI (2), FKX (1), FJK (1), ONW (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 7 (0 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: 4 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)
- Nikkiso CO., LTD.: 1 (https://510kreport.com/company/nikkiso)

## Firms that cite its devices most
- Fresenius Medical Care Renal Therapies Group, LLC: 2 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Home Dialysis Plus: 2 (https://510kreport.com/company/home-dialysis-plus)
- Fresenius Medical Care North America: 2 (https://510kreport.com/company/fresenius-medical-care-north-america)

## Its most-cited devices
- K123630: Fresenius Liberty Cycler (2013), cited by 2
- K101715: Fresenius 2008T Hemodialysis Machine Model 190573 (2010), cited by 1
- K120823: BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (2012), cited by 1
- K120505: Fresenius 2008T Hemodialysis Machine (2012), cited by 1
- K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) (2013), cited by 1

## Recent decisions
- K123630: Fresenius Liberty Cycler (Sep 9, 2013)
- K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) (Jan 17, 2013)
- K120823: BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (Jun 15, 2012)
- K120505: Fresenius 2008T Hemodialysis Machine (Mar 6, 2012)
- K101715: Fresenius 2008T Hemodialysis Machine Model 190573 (Dec 21, 2010)

Source page: https://510kreport.com/company/fresenius-medical-care-north-america-design-cente