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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 / October 2025 / K251835

510(k) cleared

Yomi Robotic System

Neocis, Inc. · Oct 10, 2025 · K251835

FDA cleared the Yomi Robotic System from Neocis, Inc. on Oct 10, 2025 under K251835, a traditional 510(k). The device falls under product code PLV, Dental Stereotaxic Instrument, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 16, 2025. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neocis, Inc. has one other decision in the tracker over the last 12 months: K252376 (Yomi S Robotic System).

Questions & Answers

What did FDA clear under K251835?

K251835 is the FDA 510(k) for Yomi Robotic System, submitted by Neocis, Inc.. FDA's decision date was Oct 10, 2025, under product code PLV (Dental Stereotaxic Instrument).

Who makes the Yomi Robotic System?

Neocis, Inc., based in Miami, FL, is the applicant of record for K251835.

How long did the K251835 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Oct 10, 2025, 116 days later.

← All decisions in October 2025