Data / Medical devices / Ireland / Aerogen Ltd.
Aerogen Ltd.: FDA-registered device maker in GALWAY Galway(County), Ireland, 6 510(k) clearances
Aerogen Ltd. is registered with the FDA (registration 3004127293) in GALWAY Galway(County), Ireland. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004127293
- Address
- M&M Qualtech, Parkmore Business Park, GALWAY Galway(County), Ireland, --
- Owner or operator
- Aerogen Ltd. (10024694)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 19, 2008
- Registered through
- 2026
- Brand names listed
- Aerogen Ltd, Aerogen Pro-X1 Controller System, Aerogen Solo Nebulizer System, Aerogen USB Controller System, Aerogen Ultra, Aerogen Ultra BV Filter, Aerogen® Solo Nebulizer System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ventilator-Compatible Nebulizer | SFP | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 2025 | K251615 | Aerogen Pro-X1 Controller System | SFP | Substantially Equivalent | Aerogen, Ltd. | accessdata.fda.gov |
| May 10, 2024 | K232507 | Aerogen®Solo Nebulizer System | CAF | Substantially Equivalent | Aerogen, Ltd. | accessdata.fda.gov |
| July 10, 2015 | K143719 | Aeroneb USB Contoller System | CAF | Substantially Equivalent | Aerogen Limited | accessdata.fda.gov |
| October 17, 2014 | K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | CAF | Substantially Equivalent | Aerogen, Ltd. | accessdata.fda.gov |
| May 7, 2007 | K070642 | AERONEB PROFESSIONAL NEBULIZER SYSTEM | CAF | Substantially Equivalent | Aerogen (Ireland), Ltd. | accessdata.fda.gov |
| July 7, 2003 | K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | CAH | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Ventilator-Compatible Nebulizer
- All makers of Nebulizer (Direct Patient Interface)
Updated September 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.