# K232507: Aerogen®Solo Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Aerogen, Ltd.
- Decided: May 10, 2024 after 266 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- 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
Longest line of descent: 2 generations back to K070642 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133360: Aeroneb Solo; Aeroneb Solo Adapter, Aerogen, Ltd. (2014) Summary page 5.

## Indications for use
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment. Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients. The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment. Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.

Source page: https://510kreport.com/device/K232507
Methodology: https://510kreport.com/methodology