510(k) K260128

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes by Becton, Dickinson and Company — Product Code JKA

K260128 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes". The FDA issued a decision of Substantially Equivalent on April 15, 2026. 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 and Company has at least 10 other 510(k) clearances on record.