AIRICU, Inc. · Class II · Cleared Mar 12, 2026
| K-number | K251584 |
| Device name | Medical Mesh Nebulizer (AirICU Max+) |
| Applicant | AIRICU, Inc. |
| Product code | SFP |
| Device class | Class II |
| Decision date | Mar 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The AirICU Max+ is a portable medical mesh nebulizer intended to aerosolize physician-prescribed solutions for inhalation in patients on or off ventilation or other positive pressure breathing assistance. It is designed for single patient use in adults aged 22 years and older who require nebulization therapy.
Not stated in this summary.
The device is subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action).
The device has been determined to be substantially equivalent to legally marketed predicate devices or devices reclassified under the Federal Food, Drug, and Cosmetic Act that do not require PMA approval. The specific predicate device comparison is not detailed in this clearance letter.
View the full FDA submission: accessdata.fda.gov