FDA applicant

Fresenius Kabi USA,Llc

Lake Zurich, IL2 decisions2016–20184 recalls

FDA records 2 decisions for Fresenius Kabi USA,Llc (Lake Zurich, IL) from 2016 to 2018: 2 510(k) clearances. Most are in product codes LKN (Separator, Automated, Blood Cell And Plasma…) and GKT (Separator, Automated, Blood Cell, Diagnostic). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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, hematology panel, where it files most

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

FDA decisions per year

1in 2018

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2023

2016high 2 (2021) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Fresenius Kabi USA,Llc by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fresenius Kabi USA,Llc’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

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 53 Fresenius Medical Care North America 43 Fresenius USA, Inc. 38 Fresenius Kabi AG 14 Fresenius Medical Care 7 Fresenius Medical Care North America, Design Cente 5 Fresenius Hemotechnology, Inc. 3 Fresenius Pharma 3 Fresenius AG 2 Fresenius Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius/Delmed, Inc. 2 Fresenius Hemocare, Inc. 1

Fresenius Kabi USA,Llc

Which product codes does it file in?

Whose devices does it build on?

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Which of its devices are cited most?

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Other applicant names beginning “Fresenius”