510(k) K250616

Clave™ Neutral-Displacement Needlefree Connectors by Icu Medical, Inc. — Product Code FPA

K250616 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "Clave™ Neutral-Displacement Needlefree Connectors". The FDA issued a decision of Substantially Equivalent on June 5, 2025. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.