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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 / July 2026 / K254038

510(k) cleared

Motivista (CT-155)

Click Therapeutics, Inc. · Jul 30, 2026 · K254038

FDA cleared the Motivista (CT-155) from Click Therapeutics, Inc. on Jul 30, 2026 under K254038, a traditional 510(k). The device falls under product code SAP, Computerized Behavioral Therapy Device For Depressive Disorders., regulated at 21 CFR 882.5801 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 16, 2025. The decision came 226 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Click Therapeutics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254038?

K254038 is the FDA 510(k) for Motivista (CT-155), submitted by Click Therapeutics, Inc.. FDA's decision date was Jul 30, 2026, under product code SAP (Computerized Behavioral Therapy Device For Depressive Disorders.).

Who makes the Motivista (CT-155)?

Click Therapeutics, Inc., based in New York, NY, is the applicant of record for K254038.

How long did the K254038 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jul 30, 2026, 226 days later.

← All decisions in July 2026