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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 / K250815

510(k) cleared

Hubly Drill (H100)

Hubly, Inc. · Nov 6, 2025 · K250815

FDA cleared the Hubly Drill (H100) from Hubly, Inc. on Nov 6, 2025 under K250815, a traditional 510(k). The device falls under product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered), regulated at 21 CFR 882.4310 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 17, 2025. The decision came 234 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hubly, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250815?

K250815 is the FDA 510(k) for Hubly Drill (H100), submitted by Hubly, Inc.. FDA's decision date was Nov 6, 2025, under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)).

Who makes the Hubly Drill (H100)?

Hubly, Inc., based in Lisle, IL, is the applicant of record for K250815.

How long did the K250815 review take?

FDA received the submission on Mar 17, 2025 and issued its decision on Nov 6, 2025, 234 days later.

← All decisions in November 2025