# K251584: Medical Mesh Nebulizer (AirICU Max+)

- Pathway: 510(k) (Traditional)
- Applicant: AIRICU, Inc.
- Decided: Mar 12, 2026 after 293 days
- Product code: SFP (Ventilator-Compatible Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AirlCU Max+ is a portable medical device for single patients use. It is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. It is suitable for adults (>22 year old) who require nebulization therapy.

Source page: https://510kreport.com/device/K251584
Methodology: https://510kreport.com/methodology