SFP
- Product code
- SFP
- Device name
- Ventilator-Compatible Nebulizer
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5630
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
FDA classification definition
The device is intended to deliver nebulized medications through a ventilator breathing circuit.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251584 | 2026-03-12 | AIRICU, Inc. | Medical Mesh Nebulizer (AirICU Max+) | — |
| K251615 | 2025-09-02 | Aerogen, Ltd. | Aerogen Pro-X1 Controller System |
Official FDA classification page: SFP
Classification and pathway per current FDA publications. Data from openFDA (CC0).