SFP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ventilator-Compatible Nebulizer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Medical specialty
- Anesthesiology
- FDA definition
- The device is intended to deliver nebulized medications through a ventilator breathing circuit.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Medical Mesh Nebulizer (AirICU Max+) (K251584) | AIRICU, Inc. | 2026-03-12 |
| Aerogen Pro-X1 Controller System (K251615) | Aerogen, Ltd. | 2025-09-02 |
Track SFP automatically
Every clearance here is in the API, with alerts when new ones post.