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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 / December 2025 / K252841

510(k) cleared

REAL INTELLIGENCE CORI XT (CORI XT)

Blue Belt Technologies, Inc. · Dec 5, 2025 · K252841

FDA cleared the REAL INTELLIGENCE CORI XT (CORI XT) from Blue Belt Technologies, Inc. on Dec 5, 2025 under K252841, a traditional 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 Sep 8, 2025. The decision came 88 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: K260601 (REAL INTELLIGENCE CORI).

Questions & Answers

What did FDA clear under K252841?

K252841 is the FDA 510(k) for REAL INTELLIGENCE CORI XT (CORI XT), submitted by Blue Belt Technologies, Inc.. FDA's decision date was Dec 5, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the REAL INTELLIGENCE CORI XT (CORI XT)?

Blue Belt Technologies, Inc., based in Pittsburgh, PA, is the applicant of record for K252841.

How long did the K252841 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Dec 5, 2025, 88 days later.

← All decisions in December 2025

Sources