K251584 is an FDA 510(k) clearance for the Medical Mesh Nebulizer (AirICU Max+). This device is classified as a Ventilator-compatible Nebulizer (Class II - Special Controls, product code SFP).
Submitted by AIRICU, Inc. (City Of Industry, US). The FDA issued a Cleared decision on March 12, 2026, 293 days after receiving the submission on May 23, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630. The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit..
| 510(k) Number | K251584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | SFP — Ventilator-compatible Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |
| Definition | The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit. |