FDA 510(k)

Medical Mesh Nebulizer (AirICU Max+)

K-Number: K251584 · 2026-03-12

Decision Date2026-03-12

Product CodeSFP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Medical Mesh Nebulizer (AirICU Max+) is the device name listed in this FDA 510(k) record. The listed applicant is AIRICU, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K251584. The device is classified under product code SFP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Mesh Nebulizer (AirICU Max+)?

Medical Mesh Nebulizer (AirICU Max+) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is AIRICU, Inc.. The 510(k) number is K251584.

When did Medical Mesh Nebulizer (AirICU Max+) receive FDA 510(k) clearance?

Medical Mesh Nebulizer (AirICU Max+) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K251584.

Who is the listed applicant for Medical Mesh Nebulizer (AirICU Max+)?

The FDA 510(k) record lists AIRICU, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Mesh Nebulizer (AirICU Max+)?

The FDA product code for Medical Mesh Nebulizer (AirICU Max+) is SFP.

Related Devices (Code: SFP)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.