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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 / January 2026 / K252755

510(k) cleared

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Point Robotics MedTech, Inc. · Jan 23, 2026 · K252755

FDA cleared the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System from Point Robotics MedTech, Inc. on Jan 23, 2026 under K252755, 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 Aug 29, 2025. The decision came 147 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: K252989 (POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set).

Questions & Answers

What did FDA clear under K252755?

K252755 is the FDA 510(k) for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System, submitted by Point Robotics MedTech, Inc.. FDA's decision date was Jan 23, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?

Point Robotics MedTech, Inc., based in New Taipei City, is the applicant of record for K252755.

How long did the K252755 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Jan 23, 2026, 147 days later.

← All decisions in January 2026

Sources