Cleared Traditional

Portable mesh nebulizer (JM821)

K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Anesthesiology

Sep 2025

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K244035 is an FDA 510(k) clearance for the Portable mesh nebulizer (JM821), a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Shenzhen Jermei Medical Device Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 19, 2025, 263 days after receiving the submission on December 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K244035 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2024
Decision Date	September 19, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF