# K123614: Solarys Ventilator Aerosol Delivery System (as)

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: Mar 11, 2013 after 108 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: 1 generation back to K070642 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070642: Aeroneb Professional Nebulizer System, Aerogen (Ireland), Ltd. (2007) Summary page 1.

## Indications for use
Salarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.

Source page: https://510kreport.com/device/K123614
Methodology: https://510kreport.com/methodology