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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 / March 2026 / K254059

510(k) cleared

Access anti-HBc IgM

Beckman Coulter, Inc. · Mar 13, 2026 · K254059

FDA cleared the Access anti-HBc IgM from Beckman Coulter, Inc. on Mar 13, 2026 under K254059, a traditional 510(k). The device falls under product code SEI, Qualitative And Quantitative Hepatitis B Virus Antibody Assays, regulated at 21 CFR 866.3173 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 17, 2025. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Beckman Coulter, Inc. has 6 other decisions in the tracker over the last 12 months: K252169 (Access BNP II), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM), K250588 (Access Rubella IgG).

Questions & Answers

What did FDA clear under K254059?

K254059 is the FDA 510(k) for Access anti-HBc IgM, submitted by Beckman Coulter, Inc.. FDA's decision date was Mar 13, 2026, under product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays).

Who makes the Access anti-HBc IgM?

Beckman Coulter, Inc., based in Brea, CA, is the applicant of record for K254059.

How long did the K254059 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Mar 13, 2026, 86 days later.

← All decisions in March 2026

Sources