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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 / K260281

510(k) cleared

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

BIOMERIEUX · Mar 26, 2026 · K260281

FDA cleared the VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) from BIOMERIEUX on Mar 26, 2026 under K260281, a traditional 510(k). The device falls under product code LON, System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, regulated at 21 CFR 866.1645 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 29, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

BIOMERIEUX has 2 other decisions in the tracker over the last 12 months: K260160 (VITEK REVEAL GN AST Assay and VITEK REVEAL AST System), K260282 (VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance).

Questions & Answers

What did FDA clear under K260281?

K260281 is the FDA 510(k) for VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), submitted by BIOMERIEUX. FDA's decision date was Mar 26, 2026, under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).

Who makes the VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)?

BIOMERIEUX, based in Hazelwood, MO, is the applicant of record for K260281.

How long did the K260281 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Mar 26, 2026, 56 days later.

← All decisions in March 2026

Sources