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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 / K253105

510(k) cleared

HardyDisk AST Cefiderocol 30µg (FDC30)

Hardy Diagnostics · Nov 20, 2025 · K253105

FDA cleared the HardyDisk AST Cefiderocol 30µg (FDC30) from Hardy Diagnostics on Nov 20, 2025 under K253105, 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 Sep 24, 2025. The decision came 57 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: K260842 (HardyDisk AST Gepotidacin 10µg (GEP10)).

Questions & Answers

What did FDA clear under K253105?

K253105 is the FDA 510(k) for HardyDisk AST Cefiderocol 30µg (FDC30), submitted by Hardy Diagnostics. FDA's decision date was Nov 20, 2025, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the HardyDisk AST Cefiderocol 30µg (FDC30)?

Hardy Diagnostics, based in Santa Maria, CA, is the applicant of record for K253105.

How long did the K253105 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Nov 20, 2025, 57 days later.

← All decisions in November 2025

Sources