# K103635: Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S

- Pathway: 510(k) (Special)
- Applicant: Aerogen, Ltd.
- Decided: May 13, 2011 after 151 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
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 Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeronebt Professional Nebulizer System is suitable for use in adult and pediatric patients.

Source page: https://510kreport.com/device/K103635
Methodology: https://510kreport.com/methodology