Clearance Summary
AdheResp Smart Breath-actuated Mesh Nebulizer received FDA 510(k) clearance under submission number K250583, sponsored by Hcmed Innovations Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-06-20.
- Submission: K250583
- Applicant / Sponsor: Hcmed Innovations Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2025-06-20
Classification & Regulation
This clearance is catalogued under FDA product code CAF and 21 CFR 868.5630, within the Anesthesiology review panel as a Class II device.