# Fresenius Medical Care

- Location (FDA's records): Lexington, MA
- FDA decisions: 7 (2000–2024): 7 510(k) clearances
- Product codes: KDI (3), KOC (2), KPO (1), FIE (1)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 24 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fresenius Medical Care Renal Therapies Group, LLC: 4 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Fresenius USA, Inc.: 3 (https://510kreport.com/company/fresenius-usa)
- Fresenius Medical Care North America: 2 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Nephros, Inc.: 1 (https://510kreport.com/company/nephros)
- Aksys, Ltd.: 1 (https://510kreport.com/company/aksys)
- Bio-Plexus, Inc.: 1 (https://510kreport.com/company/bio-plexus)
- Jms Co., Ltd.: 1 (https://510kreport.com/company/jms)
- Medisystems Corp.: 1 (https://510kreport.com/company/medisystems)

## Firms that cite its devices most
- Fresenius Medical Care Renal Therapies Group, LLC: 5 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Fresenius Medical Care North America: 4 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Davita Clinical Research (Trri): 1 (https://510kreport.com/company/davita-clinical-research-trri)
- Nxstage Medical, Inc.: 1 (https://510kreport.com/company/nxstage-medical)
- Fresenius Medical Care, North America - Renal Ther: 1 (https://510kreport.com/company/fresenius-medical-care-north-america-renal-ther)

## Its most-cited devices
- K994267: Fresenius 2008K (2000), cited by 8
- K231534: 5008X Hemodialysis System (2024), cited by 1
- K111639: Fresenius 2008T Hemodialysis Machine (2011), cited by 1
- K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series (2003), cited by 1
- K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector (2002), cited by 1

## Recent decisions
- K231534: 5008X Hemodialysis System (Feb 2, 2024)
- K141997: Crit-Line IV System (Apr 1, 2015)
- K111639: Fresenius 2008T Hemodialysis Machine (Oct 21, 2011)
- K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series (May 20, 2003)
- K023162: Fresenius Punctur-Guard Fistula Needle Sets (Mar 20, 2003)
- K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector (Oct 30, 2002)
- K994267: Fresenius 2008K (Mar 16, 2000)

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