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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 / May 2026 / K252953

510(k) cleared

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc. · May 11, 2026 · K252953

FDA cleared the Velmeni for Dentists (V4D) Endo-Perio from Velmeni, Inc. on May 11, 2026 under K252953, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 16, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Velmeni, Inc. has one other decision in the tracker over the last 12 months: K254096 (VELMENI for DENTISTS (V4D) 3D).

Questions & Answers

What did FDA clear under K252953?

K252953 is the FDA 510(k) for Velmeni for Dentists (V4D) Endo-Perio, submitted by Velmeni, Inc.. FDA's decision date was May 11, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the Velmeni for Dentists (V4D) Endo-Perio?

Velmeni, Inc., based in Sunnyvale, CA, is the applicant of record for K252953.

How long did the K252953 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on May 11, 2026, 237 days later.

← All decisions in May 2026

Sources