WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / April 2026 / K260447

510(k) cleared

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

bioMérieux SA · Apr 21, 2026 · K260447

FDA cleared the ETEST Gepotidacin (GEP) (0.016-256 µg/mL) from bioMérieux SA on Apr 21, 2026 under K260447, a traditional 510(k). The device falls under product code JWY, Manual Antimicrobial Susceptibility Test Systems, regulated at 21 CFR 866.1640 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Feb 11, 2026. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for bioMérieux SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260447?

K260447 is the FDA 510(k) for ETEST Gepotidacin (GEP) (0.016-256 µg/mL), submitted by bioMérieux SA. FDA's decision date was Apr 21, 2026, under product code JWY (Manual Antimicrobial Susceptibility Test Systems).

Who makes the ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

bioMérieux SA, based in Marcy-L'Etoile, is the applicant of record for K260447.

How long did the K260447 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Apr 21, 2026, 69 days later.

← All decisions in April 2026