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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 / September 2025 / K244035

510(k) cleared

Portable mesh nebulizer (JM821)

Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 19, 2025 · K244035

FDA cleared the Portable mesh nebulizer (JM821) from Shenzhen Jermei Medical Device Technology Co., Ltd. on Sep 19, 2025 under K244035, 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 30, 2024. The decision came 263 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 Jermei Medical Device Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244035?

K244035 is the FDA 510(k) for Portable mesh nebulizer (JM821), submitted by Shenzhen Jermei Medical Device Technology Co., Ltd.. FDA's decision date was Sep 19, 2025, under product code CAF (Nebulizer (Direct Patient Interface)).

Who makes the Portable mesh nebulizer (JM821)?

Shenzhen Jermei Medical Device Technology Co., Ltd., based in Shenzhen, is the applicant of record for K244035.

How long did the K244035 review take?

FDA received the submission on Dec 30, 2024 and issued its decision on Sep 19, 2025, 263 days later.

← All decisions in September 2025