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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 / February 2026 / K253996

510(k) cleared

BD Surgiphor Antimicrobial Irrigation System (910110)

Becton, Dickinson and Company (BD) · Feb 25, 2026 · K253996

FDA cleared the BD Surgiphor Antimicrobial Irrigation System (910110) from Becton, Dickinson and Company (BD) on Feb 25, 2026 under K253996, a special 510(k). The device falls under product code FQH, Lavage, Jet, regulated at 21 CFR 880.5475 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 12, 2025. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

Becton, Dickinson and Company (BD) 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).

Questions & Answers

What did FDA clear under K253996?

K253996 is the FDA 510(k) for BD Surgiphor Antimicrobial Irrigation System (910110), submitted by Becton, Dickinson and Company (BD). FDA's decision date was Feb 25, 2026, under product code FQH (Lavage, Jet).

Who makes the BD Surgiphor Antimicrobial Irrigation System (910110)?

Becton, Dickinson and Company (BD), based in Vernon Hills, IL, is the applicant of record for K253996.

How long did the K253996 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Feb 25, 2026, 75 days later.

← All decisions in February 2026