WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K254096

510(k) cleared

VELMENI for DENTISTS (V4D) 3D

Velmeni, Inc. · Jul 23, 2026 · K254096

FDA cleared the VELMENI for DENTISTS (V4D) 3D from Velmeni, Inc. on Jul 23, 2026 under K254096, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 19, 2025. The decision came 216 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: K252953 (Velmeni for Dentists (V4D) Endo-Perio).

Questions & Answers

What did FDA clear under K254096?

K254096 is the FDA 510(k) for VELMENI for DENTISTS (V4D) 3D, submitted by Velmeni, Inc.. FDA's decision date was Jul 23, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the VELMENI for DENTISTS (V4D) 3D?

Velmeni, Inc., based in Sunnyvale, CA, is the applicant of record for K254096.

How long did the K254096 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Jul 23, 2026, 216 days later.

← All decisions in July 2026

Sources