510(k) K243985

Rio™ Drug Reconstitution Transfer Device by Icu Medical, Inc. — Product Code LHI

K243985 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "Rio™ Drug Reconstitution Transfer Device". The FDA issued a decision of Substantially Equivalent on January 22, 2025. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.