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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 / K260128

510(k) cleared

BD Preset and BD A-Line Arterial Blood Collection Syringes

Becton, Dickinson and Company · Apr 15, 2026 · K260128

FDA cleared the BD Preset and BD A-Line Arterial Blood Collection Syringes from Becton, Dickinson and Company on Apr 15, 2026 under K260128, a special 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 Jan 16, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Becton, Dickinson and Company has 8 other decisions in the tracker over the last 12 months: 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), K260184 (Onclarity Self-Collection Kit).

Questions & Answers

What did FDA clear under K260128?

K260128 is the FDA 510(k) for BD Preset and BD A-Line Arterial Blood Collection Syringes, submitted by Becton, Dickinson and Company. FDA's decision date was Apr 15, 2026, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the BD Preset and BD A-Line Arterial Blood Collection Syringes?

Becton, Dickinson and Company, based in Franklin Lakes, NJ, is the applicant of record for K260128.

How long did the K260128 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Apr 15, 2026, 89 days later.

← All decisions in April 2026