510(k) K251584
K251584 is an FDA 510(k) premarket notification submitted by AIRICU, Inc. for the device "Medical Mesh Nebulizer (AirICU Max+)". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code SFP (Ventilator-Compatible Nebulizer), a Class II device regulated under 21 CFR 868.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- May 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator-Compatible Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
The device is intended to deliver nebulized medications through a ventilator breathing circuit.