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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 / August 2026 / K252853

510(k) cleared

CAD - Lower GI (EC07-01)

Xiamen Inno Medical Technology Co., Ltd. · Aug 5, 2026 · K252853

FDA cleared the CAD - Lower GI (EC07-01) from Xiamen Inno Medical Technology Co., Ltd. on Aug 5, 2026 under K252853, a traditional 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 8, 2025. The decision came 331 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 Xiamen Inno Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252853?

K252853 is the FDA 510(k) for CAD - Lower GI (EC07-01), submitted by Xiamen Inno Medical Technology Co., Ltd.. FDA's decision date was Aug 5, 2026, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the CAD - Lower GI (EC07-01)?

Xiamen Inno Medical Technology Co., Ltd., based in Xiamen, is the applicant of record for K252853.

How long did the K252853 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Aug 5, 2026, 331 days later.

← All decisions in August 2026