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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 / K250687

510(k) cleared

Cocoon Solo (DX-7020s)

Dexcowin Global, Inc. · Oct 24, 2025 · K250687

FDA cleared the Cocoon Solo (DX-7020s) from Dexcowin Global, Inc. on Oct 24, 2025 under K250687, a traditional 510(k). The device falls under product code MUH, System, X-Ray, Extraoral Source, Digital, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 6, 2025. The decision came 232 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 Dexcowin Global, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250687?

K250687 is the FDA 510(k) for Cocoon Solo (DX-7020s), submitted by Dexcowin Global, Inc.. FDA's decision date was Oct 24, 2025, under product code MUH (System, X-Ray, Extraoral Source, Digital).

Who makes the Cocoon Solo (DX-7020s)?

Dexcowin Global, Inc., based in Pasadena, CA, is the applicant of record for K250687.

How long did the K250687 review take?

FDA received the submission on Mar 6, 2025 and issued its decision on Oct 24, 2025, 232 days later.

← All decisions in October 2025