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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 / K252376

510(k) cleared

Yomi S Robotic System

Neocis, Inc. · Oct 28, 2025 · K252376

FDA cleared the Yomi S Robotic System from Neocis, Inc. on Oct 28, 2025 under K252376, 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 Jul 30, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Neocis, Inc. has one other decision in the tracker over the last 12 months: K251835 (Yomi Robotic System).

Questions & Answers

What did FDA clear under K252376?

K252376 is the FDA 510(k) for Yomi S Robotic System, submitted by Neocis, Inc.. FDA's decision date was Oct 28, 2025, under product code PLV (Dental Stereotaxic Instrument).

Who makes the Yomi S Robotic System?

Neocis, Inc., based in Miami, FL, is the applicant of record for K252376.

How long did the K252376 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Oct 28, 2025, 90 days later.

← All decisions in October 2025