# K032849: Aeroneb GO Nebulizer, Model AG-AG2000

- Pathway: 510(k) (Traditional)
- Applicant: Aerogen, Inc.
- Decided: Nov 21, 2003 after 70 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923024 (1992). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970010: FPT Nebulizer, Fluid Propulsion Technologies, Inc. (1997)
- K003022: Aeroneb Portable Nebulizer, Aerogen, Inc. (2000)
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.
- K923024: NE-U04/NE U04F, Omron Healthcare, Inc. (1992) Summary page 1.

## Most influential descendants
- K162041: Airworks Nebulizer pe1200m (2017), 0 descendants of its own

## Recalls of this device
- Sep 7, 2004 · Not classified · Z-0177-05: The nebulizer can either fail or provide a low flow (partial dose) of medication

## 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/K032849
Methodology: https://510kreport.com/methodology