510(k) Report

FDA applicant

Fresenius Medical Care

Lexington, MA7 decisions2000–202424 recalls

FDA records 7 decisions for Fresenius Medical Care (Lexington, MA) from 2000 to 2024: 7 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KOC (Accessories, Blood Circuit, Hemodialysis). Its devices cite 14 predicates, 0 of them its own earlier devices. 24 recalls are linked to its devices, 2 Class I.

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’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 12015: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2008: 22009: 12012: 11, 2 Class I2013: 22014: 22015: 22018: 32025: 1
2007high 11 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Fresenius Medical Care’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 System3decisions
  • KOCAccessories, Blood Circuit, Hemodialysis2decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)1decision
  • FIENeedle, Fistula1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 0 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.

  • K994267Fresenius 2008KFresenius Medical Care · 20008cite it
  • K2315345008X Hemodialysis SystemFresenius Medical Care · 20241cites it
  • K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 20111cites it
  • K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care · 20031cites it
  • K022536\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving ConnectorFresenius Medical Care · 20021cites it

What has FDA decided for it lately?

  • K2315345008X Hemodialysis SystemFresenius Medical Care · 20241 recall
  • K141997Crit-Line IV SystemFresenius Medical Care · 2015
  • K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 20111 recall
  • K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care · 20032 Class I recalls
  • K023162Fresenius Punctur-Guard Fistula Needle SetsFresenius Medical Care · 2003
  • K022536\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving ConnectorFresenius Medical Care · 20023 recalls
  • K994267Fresenius 2008KFresenius Medical Care · 20005 recalls

All 7 as Fresenius Medical Care →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K2315345008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models…Apr 29, 2025Class II
  • K030497Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number…Oct 9, 2018Class III
  • K030497Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number…Oct 9, 2018Class III
  • K030497Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number…Oct 9, 2018Class III
  • K9942672008 Series Hemodialysis Machines: 2008K2 with the following product code and…Feb 20, 2015Class II
  • K9942672008 Series Hemodialysis Machines: 2008K with the following product code and…Feb 20, 2015Class II

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 USA, Inc. 38Fresenius Kabi AG 14Fresenius 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