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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 / November 2025 / K251659

510(k) cleared

Mesh Nebulizer (H6)

Qingdao Future Medical Technology Co., Ltd. · Nov 14, 2025 · K251659

FDA cleared the Mesh Nebulizer (H6) from Qingdao Future Medical Technology Co., Ltd. on Nov 14, 2025 under K251659, a traditional 510(k). The device falls under product code CAF, Nebulizer (Direct Patient Interface), regulated at 21 CFR 868.5630 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 30, 2025. The decision came 168 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 Qingdao Future Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251659?

K251659 is the FDA 510(k) for Mesh Nebulizer (H6), submitted by Qingdao Future Medical Technology Co., Ltd.. FDA's decision date was Nov 14, 2025, under product code CAF (Nebulizer (Direct Patient Interface)).

Who makes the Mesh Nebulizer (H6)?

Qingdao Future Medical Technology Co., Ltd., based in Qingdao, is the applicant of record for K251659.

How long did the K251659 review take?

FDA received the submission on May 30, 2025 and issued its decision on Nov 14, 2025, 168 days later.

← All decisions in November 2025