Cleared Traditional

AdheResp Smart Breath-actuated Mesh Nebulizer

K250583 · Hcmed Innovations Co., Ltd. · Anesthesiology

Jun 2025

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K250583 is an FDA 510(k) clearance for the AdheResp Smart Breath-actuated Mesh Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Hcmed Innovations Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on June 20, 2025, 113 days after receiving the submission on February 27, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K250583 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2025
Decision Date	June 20, 2025
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF