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The Tracker / September 2026 / K254171

510(k) cleared

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

Shenzhen Mericonn Technology Co., Ltd. · Sep 18, 2026 · K254171

FDA cleared the Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) from Shenzhen Mericonn Technology Co., Ltd. on Sep 18, 2026 under K254171, 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 Dec 23, 2025. The decision came 269 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 Shenzhen Mericonn Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254171?

K254171 is the FDA 510(k) for Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210), submitted by Shenzhen Mericonn Technology Co., Ltd.. FDA's decision date was Sep 18, 2026, under product code CAF (Nebulizer (Direct Patient Interface)).

Who makes the Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)?

Shenzhen Mericonn Technology Co., Ltd., based in Shenzhen, is the applicant of record for K254171.

How long did the K254171 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 18, 2026, 269 days later.

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