DeviceClearance

Product code SFP— Anesthesiology

Aerogen Pro-X1 Controller System

Classification name
Ventilator-Compatible Nebulizer
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SFP under 21 CFR 868.5630, via openFDA

Market context for product code SFP

FDA has cleared 2 devices under product code SFP between 2025 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SFP

Recent clearances under product code SFP

Data sourced from openFDA. This site is unofficial and independent of the FDA.