# Fresenius USA, Inc.

- Location (FDA's records): Concord, CA
- FDA decisions: 38 (1984–1999): 38 510(k) clearances
- Product codes: KDI (6), KPO (4), FKP (4), KDJ (3), JGS (2), CEM (2), LKN (2), FIL (1), MQS (1), KNT (1), EKX (1), KPF (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 23 (1 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Colorado Medical, Inc.: 2 (https://510kreport.com/company/colorado-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Amicon, Inc.: 1 (https://510kreport.com/company/amicon)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- Bentley Laboratories, Inc.: 1 (https://510kreport.com/company/bentley-laboratories)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)

## Firms that cite its devices most
- Fresenius Medical Care North America: 4 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Fresenius Medical Care: 3 (https://510kreport.com/company/fresenius-medical-care)
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)
- Advanced Renal Technologies, Inc.: 2 (https://510kreport.com/company/advanced-renal-technologies)
- Nipro Medical Corporation: 2 (https://510kreport.com/company/nipro-medical)
- Aksys, Ltd.: 2 (https://510kreport.com/company/aksys)
- Rockwell Medical Technologies, Inc.: 1 (https://510kreport.com/company/rockwell-medical-technologies)
- Fresenius Medical Care Renal Therapies Group, LLC: 1 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)

## Its most-cited devices
- K911459: Granulyte Powder Dialysate Concentrate and Mixing (1991), cited by 3
- K922005: Granulyte Dialysate Concentrate (1994), cited by 2
- K921456: Fresenius 3008/FDS-08 Dialysate Delivery System (1994), cited by 2
- K895435: Fresenius as 104 Cell Separator (1990), cited by 2
- K926005: Fresenius Hemoflow, Various Models (1994), cited by 2
- K890824: Fresenius 2008 Touch Panel Control Dialysis System (1989), cited by 2

## Recent decisions
- K992275: Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing Set F3000TS (Aug 4, 1999)
- K970700: Fresenius Polysulfone Hemodialyzers, Both Low and High Flux (Sep 15, 1998)
- K974584: Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS (May 14, 1998)
- K973378: C.a.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model 900 510 1, PSQ Set (DD) Model 61 (Nov 3, 1997)
- K961465: 2008H on Line Clearance Monitor (Jul 3, 1997)
- K955762: Packpd Peritoneal Dialysis Urea Kinetic Modeling Software Program (Jul 31, 1996)
- K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator (Jul 31, 1996)
- K941460: Fresenius Blood Temperature Monitor (Jul 3, 1996)

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