510(k) · Cleared
ClearedAerogen®Solo Nebulizer System
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 May 10, 2024 as substantially equivalent to K133360 (Aerogen, Ltd., 2014) after a 266-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- May 10, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070642 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K133360 | Aeroneb Solo; Aeroneb Solo AdapterSummary page 5…868.5630 Product Code: CAF Classification Name: Nebulizer Primary Predicate Device: K133360 - Aeroneb® Solo Nebulizer System / Aeroneb® Solo Proprietary or Trade Name: Adapter Common/Usual Name:… | 2014 |
| † | K143719 | Aeroneb USB Contoller System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K133360.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment. Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients. The Aerogen® USB Controller System includes the Aerogen®…
Read the full statement (121 words)
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232507: Aerogen®Solo Nebulizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232507
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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