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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 / May 2026 / K260321

510(k) cleared

HipGuide (V 1.0.0.0)

Orthopedic Driven Imaging, LLC · May 8, 2026 · K260321

FDA cleared the HipGuide (V 1.0.0.0) from Orthopedic Driven Imaging, LLC on May 8, 2026 under K260321, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 30, 2026. The decision came 98 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 Orthopedic Driven Imaging, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260321?

K260321 is the FDA 510(k) for HipGuide (V 1.0.0.0), submitted by Orthopedic Driven Imaging, LLC. FDA's decision date was May 8, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the HipGuide (V 1.0.0.0)?

Orthopedic Driven Imaging, LLC, based in Gainesville, FL, is the applicant of record for K260321.

How long did the K260321 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on May 8, 2026, 98 days later.

← All decisions in May 2026