Medical Mesh Nebulizer (AirICU Max+)— 510(k) K251584
Substantially EquivalentAIRICU, Inc.
FDA 510(k) clearance K251584 for Medical Mesh Nebulizer (AirICU Max+), Substantially Equivalent on 2026-03-12. Applicant: AIRICU, Inc.. Device class: 2.
Summary
AIRICU's Medical Mesh Nebulizer (AirICU Max+) is filed under SFP, ventilator-compatible nebulizers. The record doesn't describe the nebulizer beyond its name and that code name.
Class II, 21 CFR 868.5630. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).
AIRICU filed from City Of Industry, California. The decision came 293 calendar days after receipt (May 23, 2025 to March 12, 2026).
Clearance details
- Applicant
- AIRICU, Inc.
- Product code
- Product code SFP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- City Of Industry, CA, US
Recent devices under product code SFP
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