Model note · Nebulizer
Aerogen Solo
The Aerogen Solo is a single patient vibrating mesh nebuliser that sits in line in a ventilator circuit, or on a mask or mouthpiece, to deliver prescribed inhaled drugs in hospital. It is driven by the reusable Aerogen Pro-X or USB controller and can run intermittent 30 minute doses or continuous nebulisation. Because it adds no gas flow and can be refilled without breaking the circuit, it suits ventilated and intensive care patients aged 29 days and older.
The model
Maker, model and type.
- Maker
- Aerogen Ltd
- Model
- Aerogen Solo
- Device type
- Nebulizer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Aerosol generation | Vibrating mesh (aperture plate) at approximately 128 kHz | Source |
| Nebuliser capacity | Maximum 6 mL | Source |
| Flow rate | Above 0.2 mL/min, average about 0.38 mL/min | Source |
| Particle size | Specification 1 to 5 micrometres MMAD, average tested 3.1 micrometres (Andersen cascade impactor) | Source |
| Residual volume | Under 0.1 mL for a 3 mL dose | Source |
| Operating limits | Specified performance at circuit pressures up to 90 cmH2O and 5 to 45 C | Source |
| Nebuliser size and weight | 67 x 48 x 25 mm; 13.5 g with plug | Source |
| Pro-X controller power | FRIWO AG-AP1040-US adapter (100 to 240 VAC in, 9 V out) or internal NiMH battery (4.8 V nominal); 8 W charging, 2 W nebulising; 4 kV patient isolation | Source |
| Validated life | Intermittent use up to 28 days at 4 treatments a day; continuous use up to 7 days with the continuous nebulisation tube set | Source |
| FDA clearance | K232507, Aerogen Solo Nebulizer System, product code CAF, decided 10 May 2024 | Source |
Recalls
Known FDA recalls.
- Z-0118-20152014-09-02
FRIWO mains adapter used with Aeroneb Solo and Pro controllers: cover could break and come away from the adapter body.
FDA record
Safety
Safety warnings from the record.
- Single patient use only, to prevent cross infection; do not autoclave any part. Source
- Do not nebulise alcohol based drugs, which can ignite in oxygen rich air, and do not use near flammable anaesthetic mixtures. Source
- Do not press on the domed aperture plate, push out the aerosol generator, add drug with a needle, or try to clean the nebuliser. Source
- Never place a filter or HME between the nebuliser and the patient airway, and fit a bacteria filter on the ventilator expiratory inlet. Source
- Do not use the controller near MRI or other strong electromagnetic fields, or place it in an incubator. Source
Sources
Where this note comes from.
- Aerogen Solo System Instruction Manual 30-674 Rev L (US), hosted by Hamilton Medical
- FDA 510(k) K232507 summary, Aerogen Solo Nebulizer System
- FDA recall Z-0118-2015, FRIWO adapter
- openFDA MAUDE problem counts, Aerogen Solo
Not covered: There is no service manual for the nebuliser, which is disposable, and the Pro-X controller's internal service data is not public; error reporting is limited to indicator light states. Aerogen's own product page could not be opened directly, so no facts are taken from it. The 2014 adapter recall had four near identical records; only the first is listed.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Nebulizer