Baxter Gets FDA’s 510(k) Clearance of ST Set for Acute Kidney Injury Patients

Baxter International has received the FDA’s 510(k) clearance for its ST Set, which is used in continuous renal replacement therapy (CRRT).

The disposable system, which provides blood purification outside the body using a semipermeable membrane, has been available to customers in the U.S. since August 2020, when it received the FDA’s Emergency Use Authorization to treat COVID-19 patients.

The ST Set is designed for use with the company’s PrisMax or Prismaflex monitors. It was previously approved for use in Europe, the Asia-Pacific region and elsewhere in North and South America.