FDA Product Code FRF: Cleaner, Air, Medical Recirculating
Leading manufacturers include Novaerus Us, Inc., Beiang Air Tech , Ltd. and Cerrozone.
53
Total
53
Cleared
193d
Avg days
1976
Since
Declining activity -
2 submissions in the last 2 years
vs 5 in the prior period
Review times improving: avg
137d
recently vs 195d historically
FDA 510(k) Cleared Cleaner, Air, Medical Recirculating Devices (Product Code FRF)
53 devices
Cleared
Nov 14, 2025
Biomoneta Avata Rx
Biomoneta Research Private Limited
General Hospital
149d
Cleared
Nov 19, 2024
CerroZone Mini
Cerrozone, LLC
General Hospital
124d
Cleared
Jun 14, 2024
Airdog X8 Air Purifier (KJ800F-X8)
Suzhou Beiang Smart Technology Co., Ltd.
General Hospital
92d
Cleared
Sep 18, 2023
MA-40, MA-112
Medify Air, LLC
General Hospital
270d
Cleared
May 01, 2023
RIA Safeguard
Ria Tech Co., Ltd.
General Hospital
264d
Cleared
Nov 22, 2022
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
Beiang Air Tech , Ltd.
General Hospital
557d
Cleared
Sep 14, 2022
Qorda QD1
Winix, Inc.
General Hospital
163d
Cleared
Jul 01, 2022
CerroZone Mobile
Cerrozone
General Hospital
149d
Cleared
Dec 28, 2020
Novaerus NV1050
Novaerus Us, Inc.
General Hospital
322d
Cleared
Sep 15, 1976
FILTER, PARTICULATE ARRESTING
Miles Laboratories, Inc.
General Hospital
29d
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 - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA 510(k) Review Time - FRF Product Code
Recent submissions under FRF have taken an average of 137 days to reach a decision - down from 195 days historically, suggesting improved FDA processing for this classification.
FRF devices are reviewed by the General Hospital panel. Browse all General Hospital devices →