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SFP — Ventilator-Compatible Nebulizer Class II

FDA Device Classification

Classification Details

Product Code
SFP
Device Class
Class II
Regulation Number
868.5630
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

The device is intended to deliver nebulized medications through a ventilator breathing circuit.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251584airicuMedical Mesh Nebulizer (AirICU Max+)March 12, 2026
K251615aerogenAerogen Pro-X1 Controller SystemSeptember 2, 2025