510(k) Report

FDA applicant

Fresenius Medical Care North America

Lexington, MA43 decisions1998–202592 recalls

FDA records 43 decisions for Fresenius Medical Care North America (Lexington, MA) from 1998 to 2025: 43 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJK (Set, Tubing, Blood, With And Without…). Its devices cite 52 predicates, 18 of them its own earlier devices. 92 recalls are linked to its devices, 6 Class I.

FDA’s records also spell it “Fresenius Medical Care-North America”.

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 Medical Care North America’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 32008: 22009: 12010: 12011: 22012: 32013: 22014: 12015: 22017: 12025: 1
2007high 3 (2007) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12010: 42011: 52012: 32013: 72014: 13, 1 Class I2015: 72016: 32017: 22018: 22020: 312021: 22022: 22023: 12024: 6, 5 Class I2025: 1
2007high 31 (2020) · low 0 (2008)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System17decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve4decisions
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable3decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)3decisions
  • KOCAccessories, Blood Circuit, Hemodialysis3decisions
  • FIBProtector, Transducer, Dialysis2decisions

Also: ONW (2), FKX (2), LKN (2), FKP (1), MSE (1), FPA (1).

Whose devices does it build on?

Its devices cite 52 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 50 times; 18 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.

  • K043363Fresenius Liberty CyclerFresenius Medical Care North America · 20054cite it
  • K002277Fresenius Optiflux 200NRFresenius Medical Care North America · 20004cite it
  • K152367Optiflux dialyzerFresenius Medical Care North America · 20153cite it
  • K162488Optiflux dialyzerFresenius Medical Care North America · 20173cite it
  • K080964Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 20093cite it
  • K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 20123cite it

What has FDA decided for it lately?

  • K252181AquaAFresenius Medical Care North America · 2025
  • K162488Optiflux dialyzerFresenius Medical Care North America · 20174 recalls
  • K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015
  • K152367Optiflux dialyzerFresenius Medical Care North America · 20151 recall
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  • K131611Fresenius Dry Acid Dissolution UnitsFresenius Medical Care North America · 20132 recalls
  • K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
  • K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 20125 recalls

All 42 as Fresenius Medical Care North America →The one decision as Fresenius Medical Care-North America →

What has been recalled?

92 recalls linked to its devices; the latest:

  • K162488Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS…Aug 29, 2025Class II
  • K162488Dialyzer Optiflux 160NReDec 5, 2024Class II
  • K022412stay-safe /Safe Lock Catheter Ext. 12 inJan 23, 2024Class I
  • K022412stay-safe /Luer Lock Adapter 4 inJan 23, 2024Class I
  • K022412stay-safe /Luer Lock Catheter Ext. 18 inJan 23, 2024Class I
  • K022412stay-safe /Luer Catheter Ext. 6 inJan 23, 2024Class I

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 USA, Inc. 38Fresenius 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