ICU Medical Announces New FDA 510(k) cleared labeling claims for Clave™ Portfolio of Needlefree IV Connectors with Powerful New Infection Control Data

New labeling clearance highlights peer-reviewed evidence showing hospitals that standardize on Clave technology achieve significantly greater infection reduction and cost savings compared to non-Clave hospitals.

San Clemente, Calif. September 18, 2025 - ICU Medical Inc. (NASDAQ:ICUI), a global medical technology company specializing in IV therapy and critical care, today announced new 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Clave portfolio of needlefree connectors. This FDA clearance introduces a new labeling claim for peer-reviewed study data suggesting acute care hospitals that utilized Clave connectors in high volumes have a 19% lower relative risk of Central Line-Associated Bloodstream Infection (CLABSI) along with lower associated healthcare costs and reduced mortality.