# K133360: Aeroneb Solo; Aeroneb Solo Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Aerogen, Ltd.
- Decided: Oct 17, 2014 after 350 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.
4 later devices descend from it; 4 cite 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)
- K070642: Aeroneb Professional Nebulizer System, Aerogen (Ireland), Ltd. (2007) Summary page 4.
- (no number) AeroEclipse® II BAN: named in the summary without a submission number

## Most influential descendants
- 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® Solo Nebulizer System is a portable medical device for single 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® Solo Adapter is an accessory specific to the Aeroneb® Solo Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental Oxygen to pediatric (29 days or older) and adult patients in hospital use environments via a mouthpiece or aerosol mask. If supplemental oxygen is used, for pediatric patients under 18 years of age, a maximum flow rate of 2 LPM should be used. Note: The mouthpiece should not be used for children under 5 years of age.

Source page: https://510kreport.com/device/K133360
Methodology: https://510kreport.com/methodology