510(k) · Cleared
ClearedAerogen Pro-X1 Controller System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerogen, Ltd. · SFP Ventilator-Compatible Nebulizer
Cleared on Sep 2, 2025 after a 98-day review. The FDA summary names no predicate by number.
- Decided
- Sep 2, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- SFP
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 SFP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
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.
How does its category compare?
All SFP devicesSFP Ventilator-Compatible Nebulizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFP
Too few SFP 510(k)s in any year since 2007 to give a median.
Recalls per year · SFP
No recall names SFP since 2007.
Adverse event reports per year · SFP
No MAUDE report names SFP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Aerogen® Pro-X1 controller System is a portable medical device system inclusive of the Aerogen Solo Nebulizer (Single-patient, Multiple use) which is intended to aerosolize prescribed medications for inhalation to paediatric (29 days and older) and adult patients during invasive ventilation, non-invasive respiratory support or to conscious and spontaneous breathing patients in the hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251615: Aerogen Pro-X1 Controller System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251615
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026