Data / Medical devices / Ireland / Aerogen Shannon
Aerogen Shannon: FDA-registered device maker in Co. Clare, Ireland, 3 510(k) clearances
Aerogen Shannon is registered with the FDA (registration 3018070843) in Co. Clare, Ireland. It lists 2 device types. The FDA files 3 510(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
- 3018070843
- Address
- Shannon Industrial Estate Shannon, Co. Clare, Ireland, V14HN40
- Owner or operator
- Aerogen Ltd. (10024694)
- Roles
- Manufacturer
- First device listed
- February 19, 2008
- Registered through
- 2026
- Brand names listed
- Aerogen Ltd, Aerogen Pro-X1 Controller System, Aerogen Solo Nebulizer System, Aerogen® Solo Nebulizer System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator-Compatible Nebulizer | SFP | 2 | Manufacturer | 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 |
| May 7, 2007 | K070642 | AERONEB PROFESSIONAL NEBULIZER SYSTEM | CAF | Substantially Equivalent | Aerogen (Ireland), Ltd. | accessdata.fda.gov |
Compare with other makers
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.