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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 / K253445

510(k) cleared

BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)

Bd · Feb 20, 2026 · K253445

FDA cleared the BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) from Bd on Feb 20, 2026 under K253445, a traditional 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 Oct 2, 2025. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bd has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K253445?

K253445 is the FDA 510(k) for BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120), submitted by Bd. FDA's decision date was Feb 20, 2026, under product code FQH (Lavage, Jet).

Who makes the BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)?

Bd, based in Vernon Hills, IL, is the applicant of record for K253445.

How long did the K253445 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Feb 20, 2026, 141 days later.

← All decisions in February 2026