FDA applicant
Aerogen, Ltd.
FDA records 10 decisions for Aerogen, Ltd. (Galway, IE) from 2000 to 2025: 10 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and SFP (Ventilator-Compatible Nebulizer). Its devices cite 12 predicates, 5 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Aerogen, Inc.”, “Aerogen Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aerogen, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
4in 2014
Class I Class II/III not classified
Planning a device like Aerogen, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Aerogen”
FDA records each applicant name separately; these may or may not be the same firm.