# Fresenius Medical Care North America

- Location (FDA's records): Lexington, MA
- FDA decisions: 43 (1998–2025): 43 510(k) clearances
- Names in FDA's records: Fresenius Medical Care North America (42); Fresenius Medical Care-North America (1)
- Product codes: KDI (17), FJK (4), KDJ (3), KPO (3), KOC (3), FIB (2), ONW (2), FKX (2), LKN (2), FKP (1), MSE (1), FPA (1)
- Predicates its devices cite: 52 (18 its own); citations of its devices by later devices: 50 (18 its own)
- Recalls linked to its devices: 92 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 4 (https://510kreport.com/company/baxter-healthcare)
- Fresenius Medical Care: 4 (https://510kreport.com/company/fresenius-medical-care)
- Fresenius USA, Inc.: 4 (https://510kreport.com/company/fresenius-usa)
- National Medical Care, Inc.: 3 (https://510kreport.com/company/national-medical-care)
- Erika, Inc.: 3 (https://510kreport.com/company/erika)
- In-Line Diagnostics Corp.: 2 (https://510kreport.com/company/in-line-diagnostics)
- National Medical Care, Medical Products Div., Inc.: 2 (https://510kreport.com/company/national-medical-care-medical-products-div)
- Fresenius Medical Care North America, Design Cente: 2 (https://510kreport.com/company/fresenius-medical-care-north-america-design-cente)

## Firms that cite its devices most
- Fresenius Medical Care Renal Therapies Group, LLC: 10 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Fresenius Medical Care North America, Design Cente: 4 (https://510kreport.com/company/fresenius-medical-care-north-america-design-cente)
- Fresenius Medical Care: 2 (https://510kreport.com/company/fresenius-medical-care)
- Renal Solutions, Inc.: 2 (https://510kreport.com/company/renal-solutions)
- Nipro Medical Corporation: 2 (https://510kreport.com/company/nipro-medical)
- Fresenius Medical Care, North America - Renal Ther: 2 (https://510kreport.com/company/fresenius-medical-care-north-america-renal-ther)
- Toray Industries (America), Inc.: 1 (https://510kreport.com/company/toray-industries-america)
- Fresenius Medical Care Reanal Therapies Group, LLC: 1 (https://510kreport.com/company/fresenius-medical-care-reanal-therapies-group)

## Its most-cited devices
- K043363: Fresenius Liberty Cycler (2005), cited by 4
- K002277: Fresenius Optiflux 200NR (2000), cited by 4
- K152367: Optiflux dialyzer (2015), cited by 3
- K162488: Optiflux dialyzer (2017), cited by 3
- K080964: Fresenius Model 2008T Hemodialysis Machine (2009), cited by 3
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System (2012), cited by 3

## Recent decisions
- K252181: AquaA (Sep 9, 2025)
- K162488: Optiflux dialyzer (Apr 6, 2017)
- K152953: Crit-Line Clip (Clic) Blood Chamber (Nov 5, 2015)
- K152367: Optiflux dialyzer (Oct 29, 2015)
- K123262: Optiflux Ultra Dialyzer (Jan 6, 2014)
- K131611: Fresenius Dry Acid Dissolution Units (Aug 29, 2013)
- K124035: 2008K@Home Hemodialysis Machine (Jul 3, 2013)
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System (Dec 6, 2012)

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