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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 / July 2026 / K260160

510(k) cleared

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

bioMerieux, Inc. · Jul 8, 2026 · K260160

FDA cleared the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System from bioMerieux, Inc. on Jul 8, 2026 under K260160, a traditional 510(k). The device falls under product code SAN, Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, regulated at 21 CFR 866.1650 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 20, 2026. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

bioMerieux, Inc. has 2 other decisions in the tracker over the last 12 months: K260282 (VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance), K260281 (VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)).

Questions & Answers

What did FDA clear under K260160?

K260160 is the FDA 510(k) for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, submitted by bioMerieux, Inc.. FDA's decision date was Jul 8, 2026, under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples).

Who makes the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

bioMerieux, Inc., based in Hazelwood, MO, is the applicant of record for K260160.

How long did the K260160 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Jul 8, 2026, 169 days later.

← All decisions in July 2026

Sources