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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 / February 2026 / K252909

510(k) cleared

Diagnostic X-Ray Equipment Model POCT22

Ningbo Runyes Medical Instrument Co., Ltd. · Feb 3, 2026 · K252909

FDA cleared the Diagnostic X-Ray Equipment Model POCT22 from Ningbo Runyes Medical Instrument Co., Ltd. on Feb 3, 2026 under K252909, a traditional 510(k). The device falls under product code EHD, Unit, X-Ray, Extraoral With Timer, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 12, 2025. The decision came 144 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 Ningbo Runyes Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252909?

K252909 is the FDA 510(k) for Diagnostic X-Ray Equipment Model POCT22, submitted by Ningbo Runyes Medical Instrument Co., Ltd.. FDA's decision date was Feb 3, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the Diagnostic X-Ray Equipment Model POCT22?

Ningbo Runyes Medical Instrument Co., Ltd., based in Ningbo Zhejiang, is the applicant of record for K252909.

How long did the K252909 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Feb 3, 2026, 144 days later.

← All decisions in February 2026