Medical Mesh Nebulizer (AirICU Max+)
FDA 510(k) clearance K251584 · decided 2026-03-12
Clearance details
- K-number
- K251584
- Device name
- Medical Mesh Nebulizer (AirICU Max+)
- Applicant
- AIRICU, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-23
- Decision date
- 2026-03-12
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- SFP
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- City Of Industry, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aerogen Pro-X1 Controller System (K251615) | Aerogen, Ltd. | 2025-09-02 |
Recalls involving this device
No recalls on record reference this clearance.