# K081650: Aeroneb GO Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Aerogen (Ireland), Ltd.
- Decided: Oct 23, 2008 after 133 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K170853: InnoSpire Go (2017), 0 descendants of its own

## Indications for use
The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

Source page: https://510kreport.com/device/K081650
Methodology: https://510kreport.com/methodology