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FDA 510(k)

AdheResp Smart Breath-actuated Mesh Nebulizer

K-Number: K250583 · 2025-06-20

ApplicantHcmed Innovations Co., Ltd.
Decision Date2025-06-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AdheResp Smart Breath-actuated Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250583. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AdheResp Smart Breath-actuated Mesh Nebulizer?

AdheResp Smart Breath-actuated Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Hcmed Innovations Co., Ltd.. The 510(k) number is K250583.

When did AdheResp Smart Breath-actuated Mesh Nebulizer receive FDA 510(k) clearance?

AdheResp Smart Breath-actuated Mesh Nebulizer received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250583.

Who is the listed applicant for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA 510(k) record lists Hcmed Innovations Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer is CAF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05691218Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency DepartmentRECRUITING

Other records listing Hcmed Innovations Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202171Pulmogine Vibrating Mesh Nebulizer

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.K250022HeroTracker SenseVoluntis

Official Source

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