510(k) · Cleared
ClearedAeroneb Professional Nebulizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerogen (Ireland), Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on May 7, 2007 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK070642 Aeroneb Professional Nebulizer SystemAerogen (Ireland), Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK133360 Aeroneb Solo; Aeroneb Solo AdapterAerogen, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK232507 Aerogen®Solo Nebulizer SystemAerogen, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK220869 Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK211560 Airvo Nebulizer AdapterFisher & Paykel Healthcare Limited · 2021
- Descendant · 2 generations on · 0 of its ownK143719 Aeroneb USB Contoller SystemAerogen Limited · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133360Aeroneb Solo; Aeroneb Solo AdapterAerogen, Ltd. · 2014 · cites it directly4descendants
- K232507Aerogen®Solo Nebulizer SystemAerogen, Ltd. · 2024 · 2 generations on0descendants
- K220869Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022 · 2 generations on0descendants
- K211560Airvo Nebulizer AdapterFisher & Paykel Healthcare Limited · 2021 · 2 generations on0descendants
- K143719Aeroneb USB Contoller SystemAerogen Limited · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070642 | Aeroneb Professional Nebulizer System | Aerogen (Ireland), Ltd. | 2007 | — |
| +1 | K133360 | Aeroneb Solo; Aeroneb Solo Adapter | Aerogen, Ltd. | 2014 | — |
| +2 | K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024 | — |
| +2 | K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022 | — |
| +2 | K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021 | — |
| +2 | K143719 | Aeroneb USB Contoller System | Aerogen Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 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?
- Of its descendants, K133360 (Aerogen, Ltd., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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® 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070642: Aeroneb Professional 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/K070642
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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