FDA Product Code SFP: Ventilator-compatible Nebulizer
The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit.
Leading manufacturers include AIRICU, Inc. and Aerogen, Ltd..
2
Total
2
Cleared
196d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Ventilator-compatible Nebulizer Devices (Product Code SFP)
2 devices
Cleared
Mar 12, 2026
Medical Mesh Nebulizer (AirICU Max+)
AIRICU, Inc.
Anesthesiology
293d
Cleared
Sep 02, 2025
Aerogen Pro-X1 Controller System
Aerogen, Ltd.
Anesthesiology
98d
About Product Code SFP - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SFP since 2025, with 2 receiving FDA clearance (average review time: 196 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →