Fresenius Kabi AG - FDA 510(k) Cleared Devices

Fresenius Kabi AG, is a global healthcare company specializing in infusion therapy, IV drugs, and medical devices. The company operates with a manufacturing facility in Lake Zurich, Illinois, and serves hospitals and healthcare systems worldwide.

Fresenius Kabi has received 12 FDA 510(k) clearances from 12 total submissions since 2013. The company's regulatory portfolio focuses on infusion systems, administration sets, and blood processing technologies for general hospital and cardiovascular applications. The latest clearance in 2026 demonstrates continued innovation and active market engagement.

The company's cleared devices include infusion pump systems, transfer adapters, software monitoring solutions, and automated blood processing equipment. These products support critical care delivery across multiple clinical specialties, including general hospital, cardiovascular, and gastroenterology applications.

Explore the complete list of device names, product codes, and individual clearance dates in the database.

Regulatory submissions have been managed by Fresenius Kabi, LLC, USA, Fresenius Kabi and Fresenius Kabi USA.