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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 / December 2025 / K252480

510(k) cleared

CE Deliver (DLV)

CapsoVision, Inc. · Dec 19, 2025 · K252480

FDA cleared the CE Deliver (DLV) from CapsoVision, Inc. on Dec 19, 2025 under K252480, a traditional 510(k). The device falls under product code NEZ, System, Imaging, Gastrointestinal, Wireless, Capsule, regulated at 21 CFR 876.1300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 7, 2025. The decision came 134 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 CapsoVision, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252480?

K252480 is the FDA 510(k) for CE Deliver (DLV), submitted by CapsoVision, Inc.. FDA's decision date was Dec 19, 2025, under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule).

Who makes the CE Deliver (DLV)?

CapsoVision, Inc., based in Saratoga, CA, is the applicant of record for K252480.

How long did the K252480 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Dec 19, 2025, 134 days later.

← All decisions in December 2025