FDA Product Code FRA: Purifier, Air, Ultraviolet, Medical
Leading manufacturers include Healkee Medical Pte, Ltd., Uvx, Inc. and Samsung Electronics Co., Ltd..
FDA 510(k) Cleared Purifier, Air, Ultraviolet, Medical Devices (Product Code FRA)
About Product Code FRA - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code FRA since 1987, with 36 receiving FDA clearance (average review time: 209 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under FRA have taken an average of 169 days to reach a decision - down from 215 days historically, suggesting improved FDA processing for this classification.
FRA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →