510(k) K192154

Rio Vial-to-Bag Drug Reconstitution Device by Icu Medical — Product Code LHI

K192154 is an FDA 510(k) premarket notification submitted by Icu Medical for the device "Rio Vial-to-Bag Drug Reconstitution Device". The FDA issued a decision of Substantially Equivalent on April 20, 2020. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Icu Medical has at least 10 other 510(k) clearances on record.