FDA Product Code FRF: Cleaner, Air, Medical Recirculating
Leading manufacturers include Medify Air, LLC, Suzhou Beiang Smart Technology Co., Ltd. and Cerrozone, LLC.
FDA 510(k) Cleared Cleaner, Air, Medical Recirculating Devices (Product Code FRF)
About Product Code FRF - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code FRF since 1976, with 53 receiving FDA clearance (average review time: 193 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under FRF have taken an average of 122 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.
FRF devices are reviewed by the General Hospital panel. Browse all General Hospital devices →