SFP · Ventilator-Compatible Nebulizer
Anesthesiology · 21 CFR 868.5630 · Class 2
Overview
| Product Code | SFP |
|---|---|
| Device Name | Ventilator-Compatible Nebulizer |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | Mar 12, 2026 | SESE |
| K251615 | Aerogen Pro-X1 Controller System | Aerogen, Ltd. | Sep 2, 2025 | SESE |
Top Applicants
- AIRICU, Inc. — 1 clearance
- Aerogen, Ltd. — 1 clearance
