510(k) K241586

PIVO™ Pro Needle-free Blood Collection Device by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code JKA

K241586 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "PIVO™ Pro Needle-free Blood Collection Device". The FDA issued a decision of Substantially Equivalent on February 27, 2025. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.