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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 / March 2026 / K260601

510(k) cleared

REAL INTELLIGENCE CORI

Blue Belt Technologies, Inc. · Mar 26, 2026 · K260601

FDA cleared the REAL INTELLIGENCE CORI from Blue Belt Technologies, Inc. on Mar 26, 2026 under K260601, a special 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 24, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Blue Belt Technologies, Inc. has one other decision in the tracker over the last 12 months: K252841 (REAL INTELLIGENCE CORI XT (CORI XT)).

Questions & Answers

What did FDA clear under K260601?

K260601 is the FDA 510(k) for REAL INTELLIGENCE CORI, submitted by Blue Belt Technologies, Inc.. FDA's decision date was Mar 26, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the REAL INTELLIGENCE CORI?

Blue Belt Technologies, Inc., based in Pittsburgh, PA, is the applicant of record for K260601.

How long did the K260601 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Mar 26, 2026, 30 days later.

← All decisions in March 2026

Sources