BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

FDA cleared the BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes from Becton, Dickinson and Company on Mar 13, 2026 under K252040, a traditional 510(k). The device falls under product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection, regulated at 21 CFR 862.1675 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 30, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Becton, Dickinson and Company has 8 other decisions in the tracker over the last 12 months: K260128 (BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes), K252378 (BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube), K252506 (BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder), K252137 (BD Insyte™ IV Catheter).