Data / Medical devices / Ireland / Aerogen Ltd
Aerogen Ltd: FDA-registered device maker in DANGAN Galway(County), Ireland, 7 510(k) clearances
Aerogen Ltd is registered with the FDA (registration 3003399703) in DANGAN Galway(County), Ireland. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 2, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003399703
- Address
- Galway Business Park, DANGAN Galway(County), Ireland, --
- Owner or operator
- Aerogen Ltd. (10024694)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- 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, Aeroneb Professional Nebulisation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator-Compatible Nebulizer | SFP | 2 | Complaint file establishment, Specification developer | 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 13, 2011 | K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 2, 2014 | 69236 | Class II | Terminated | 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 pos | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Ventilator-Compatible Nebulizer
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.