510(k) · Cleared
ClearedAeroneb Solo; Aeroneb Solo Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerogen, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 17, 2014 as substantially equivalent to K070642 (Aerogen (Ireland), Ltd., 2007) after a 350-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 350 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070642 (2007). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK070642 Aeroneb Professional Nebulizer SystemAerogen (Ireland), Ltd. · 2007
- This deviceK133360 Aeroneb Solo; Aeroneb Solo AdapterAerogen, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK232507 Aerogen®Solo Nebulizer SystemAerogen, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220869 Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211560 Airvo Nebulizer AdapterFisher & Paykel Healthcare Limited · 2021
- Descendant · cites it directly · 0 of its ownK143719 Aeroneb USB Contoller SystemAerogen Limited · 2015
Most influential descendants
Showing 4 of 4 · See all- K232507Aerogen®Solo Nebulizer SystemAerogen, Ltd. · 2024 · cites it directly0descendants
- K220869Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022 · cites it directly0descendants
- K211560Airvo Nebulizer AdapterFisher & Paykel Healthcare Limited · 2021 · cites it directly0descendants
- K143719Aeroneb USB Contoller SystemAerogen Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070642 | Aeroneb Professional Nebulizer System | Aerogen (Ireland), Ltd. | 2007 | — |
| 0 (this device) | K133360 | Aeroneb Solo; Aeroneb Solo Adapter | Aerogen, Ltd. | 2014 | — |
| +1 | K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024 | — |
| +1 | K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022 | — |
| +1 | K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021 | — |
| +1 | K143719 | Aeroneb USB Contoller System | Aerogen Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070642 | Aeroneb Professional Nebulizer SystemSummary page 4…Classification of the Device: Class II Product Code: CAF Predicate (Cleared) Device(s): Predicate 510(k) Number: K070642 Device: Aeroneb® Solo Nebulizer System Date: May 07, 2007. Manu… | 2007 |
| * | — | AeroEclipse® II BAN Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (116 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133360: Aeroneb Solo; Aeroneb Solo Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133360
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026