# K070642: Aeroneb Professional Nebulizer System

- Pathway: 510(k) (Special)
- Applicant: Aerogen (Ireland), Ltd.
- Decided: May 7, 2007 after 60 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K133360: Aeroneb Solo; Aeroneb Solo Adapter (2014), 4 descendants of its own
- K232507: Aerogen®Solo Nebulizer System (2024), 0 descendants of its own
- K220869: Vapotherm Aerosol Adapter AAA-2 (2022), 0 descendants of its own
- K211560: Airvo Nebulizer Adapter (2021), 0 descendants of its own
- K143719: Aeroneb  USB Contoller System (2015), 0 descendants of its own

## 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 Aeroneb ® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Source page: https://510kreport.com/device/K070642
Methodology: https://510kreport.com/methodology