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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 / February 2026 / K252989

510(k) cleared

POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set

Point Robotics MedTech, Inc. · Feb 20, 2026 · K252989

FDA cleared the POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set from Point Robotics MedTech, Inc. on Feb 20, 2026 under K252989, 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 18, 2025. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Point Robotics MedTech, Inc. has one other decision in the tracker over the last 12 months: K252755 (POINT Kinguide Agile Robotic Arm Surgical Stereotactic System).

Questions & Answers

What did FDA clear under K252989?

K252989 is the FDA 510(k) for POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set, submitted by Point Robotics MedTech, Inc.. FDA's decision date was Feb 20, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

Point Robotics MedTech, Inc., based in New Taipei City, is the applicant of record for K252989.

How long did the K252989 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Feb 20, 2026, 155 days later.

← All decisions in February 2026

Sources