510(k) Report

FDA applicant

Fresenius USA, Inc.

Concord, CA38 decisions1984–19996 recalls

FDA records 38 decisions for Fresenius USA, Inc. (Concord, CA) from 1984 to 1999: 38 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 8 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Fresenius USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fresenius USA, Inc. since 2007.

Recalls per year

1in 2015

2009: 32011: 12013: 12015: 1
2007high 3 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fresenius USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fresenius USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System6decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)4decisions
  • FKPSystem, Dialysate Delivery, Single Patient4decisions
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable3decisions
  • JGSElectrode, Ion Specific, Sodium2decisions
  • CEMElectrode, Ion Specific, Potassium2decisions

Also: LKN (2), FIL (1), MQS (1), KNT (1), EKX (1), KPF (1).

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K911459Granulyte Powder Dialysate Concentrate and MixingFresenius USA, Inc. · 19913cite it
  • K922005Granulyte Dialysate ConcentrateFresenius USA, Inc. · 19942cite it
  • K921456Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 19942cite it
  • K895435Fresenius as 104 Cell SeparatorFresenius USA, Inc. · 19902cite it
  • K926005Fresenius Hemoflow, Various ModelsFresenius USA, Inc. · 19942cite it
  • K890824Fresenius 2008 Touch Panel Control Dialysis SystemFresenius USA, Inc. · 19892cite it

What has FDA decided for it lately?

  • K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing…Fresenius USA, Inc. · 1999
  • K970700Fresenius Polysulfone Hemodialyzers, Both Low and High FluxFresenius USA, Inc. · 1998
  • K974584Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSFresenius USA, Inc. · 1998
  • K973378C.a.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model 900 510 1, PSQ Set…Fresenius USA, Inc. · 1997
  • K9614652008H on Line Clearance MonitorFresenius USA, Inc. · 1997
  • K955762Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramFresenius USA, Inc. · 1996
  • K961706P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorFresenius USA, Inc. · 19961 recall
  • K941460Fresenius Blood Temperature MonitorFresenius USA, Inc. · 1996

All 38 as Fresenius USA, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K911459Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the…Oct 23, 2015Class II
  • K070049Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home…Nov 12, 2013Class II
  • K961706The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator…Apr 19, 2011
  • K921456Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis…Nov 20, 2009
  • K921456Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut…Nov 20, 2009
  • K911459Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank…Nov 20, 2009

Other applicant names beginning “Fresenius”

FDA records each applicant name separately; these may or may not be the same firm.

Fresenius Medical Care Renal Therapies Group, LLC 53Fresenius Medical Care North America 43Fresenius Kabi AG 14Fresenius Medical Care 7Fresenius Medical Care North America, Design Cente 5Fresenius Hemotechnology, Inc. 3Fresenius Pharma 3Fresenius AG 2Fresenius Medical Care South Asia Pacific Pty, Ltd. 2Fresenius Kabi USA,Llc 2Fresenius/Delmed, Inc. 2Fresenius Hemocare, Inc. 1