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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 / November 2025 / K250588

510(k) cleared

Access Rubella IgG

Beckman Coulter, Inc. · Nov 17, 2025 · K250588

FDA cleared the Access Rubella IgG from Beckman Coulter, Inc. on Nov 17, 2025 under K250588, a traditional 510(k). The device falls under product code LFX, Enzyme Linked Immunoabsorbent Assay, Rubella, regulated at 21 CFR 866.3510 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Feb 27, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beckman Coulter, Inc. has 6 other decisions in the tracker over the last 12 months: K252169 (Access BNP II), K254059 (Access anti-HBc IgM), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM).

Questions & Answers

What did FDA clear under K250588?

K250588 is the FDA 510(k) for Access Rubella IgG, submitted by Beckman Coulter, Inc.. FDA's decision date was Nov 17, 2025, under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

Who makes the Access Rubella IgG?

Beckman Coulter, Inc., based in Chaska, MN, is the applicant of record for K250588.

How long did the K250588 review take?

FDA received the submission on Feb 27, 2025 and issued its decision on Nov 17, 2025, 263 days later.

← All decisions in November 2025

Sources