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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 / May 2026 / K260842

510(k) cleared

HardyDisk AST Gepotidacin 10µg (GEP10)

Hardy Diagnostics · May 11, 2026 · K260842

FDA cleared the HardyDisk AST Gepotidacin 10µg (GEP10) from Hardy Diagnostics on May 11, 2026 under K260842, a traditional 510(k). The device falls under product code JTN, Susceptibility Test Discs, Antimicrobial, regulated at 21 CFR 866.1620 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 16, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Hardy Diagnostics has one other decision in the tracker over the last 12 months: K253105 (HardyDisk AST Cefiderocol 30µg (FDC30)).

Questions & Answers

What did FDA clear under K260842?

K260842 is the FDA 510(k) for HardyDisk AST Gepotidacin 10µg (GEP10), submitted by Hardy Diagnostics. FDA's decision date was May 11, 2026, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the HardyDisk AST Gepotidacin 10µg (GEP10)?

Hardy Diagnostics, based in Santa Maria, CA, is the applicant of record for K260842.

How long did the K260842 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on May 11, 2026, 56 days later.

← All decisions in May 2026

Sources