Data / Medical devices / Ventilator-Compatible Nebulizer
Ventilator-Compatible Nebulizer (SFP): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Ventilator-Compatible Nebulizer (product code SFP, Class 2, 21 CFR 868.5630). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on March 12, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SFP
- Device class
- 2
- Regulation
- 868.5630
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Ireland | 3 |
| China | 1 |
Makers of Ventilator-Compatible Nebulizer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aerogen Ltd | DANGAN Galway(County), Ireland | Complaint file establishment, Specification developer | 1 | September 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aerogen Ltd. | GALWAY Galway(County), Ireland | Manufacturer, Repackager or relabeler | 1 | September 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aerogen Shannon | Co. Clare, Ireland | Manufacturer | 1 | September 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Feellife Health Inc. | Shenzhen Guangdong, China | Manufacturer, Specification developer | 1 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated March 12, 2026. 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.