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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252506

510(k) cleared

BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder

Becton, Dickinson and Company · Apr 10, 2026 · K252506

FDA cleared the BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder from Becton, Dickinson and Company on Apr 10, 2026 under K252506, 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 Aug 8, 2025. The decision came 245 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), K252137 (BD Insyte IV Catheter), K260184 (Onclarity Self-Collection Kit).

Questions & Answers

What did FDA clear under K252506?

K252506 is the FDA 510(k) for BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder, submitted by Becton, Dickinson and Company. FDA's decision date was Apr 10, 2026, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder?

Becton, Dickinson and Company, based in Franklin Lakes, NJ, is the applicant of record for K252506.

How long did the K252506 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Apr 10, 2026, 245 days later.

← All decisions in April 2026