FRF · Class II · 21 CFR 880.5045

FDA Product Code FRF: Cleaner, Air, Medical Recirculating

Leading manufacturers include Hmi Industries, Inc., Novaerus Us, Inc. and Beiang Air Tech , Ltd..

53
Total
53
Cleared
193d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 4 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
1–24 of 53
Cleared Nov 14, 2025
Biomoneta Avata Rx
K251872
Biomoneta Research Private Limited
General Hospital · 149d
Cleared Nov 19, 2024
CerroZone Mini
K242102
Cerrozone, LLC
General Hospital · 124d
Cleared Jun 14, 2024
Airdog X8 Air Purifier (KJ800F-X8)
K240696
Suzhou Beiang Smart Technology Co., Ltd.
General Hospital · 92d
Cleared Sep 18, 2023
MA-40, MA-112
K223835
Medify Air, LLC
General Hospital · 270d
Cleared May 01, 2023
RIA Safeguard
K222416
Ria Tech Co., Ltd.
General Hospital · 264d
Cleared Nov 22, 2022
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
K211507
Beiang Air Tech , Ltd.
General Hospital · 557d
Cleared Sep 14, 2022
Qorda QD1
K220990
Winix, Inc.
General Hospital · 163d
Cleared Jul 01, 2022
CerroZone Mobile
K220298
Cerrozone
General Hospital · 149d
Cleared Dec 28, 2020
Novaerus NV1050
K200321
Novaerus Us, Inc.
General Hospital · 322d
Cleared Jul 23, 2013
AIRSONETT AIR-4
K130702
Airsonett AB
General Hospital · 130d
Cleared Jan 23, 2013
HEPAIRX VENTILATING AIR PURIFIER
K112728
Air Innovations, Inc.
General Hospital · 491d
Cleared Nov 07, 2008
AIRSONNETT AIRSHOWER AIR 3
K081062
Airsonett, Inc.
General Hospital · 207d
Cleared Mar 27, 2008
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
K072185
Airistar Technologies, LLC
General Hospital · 234d
Cleared Dec 14, 2007
PLASMAIR, MODEL T2006
K070722
Airinspace B.V.
General Hospital · 274d
Cleared Mar 12, 2003
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693
Airex, Inc.
General Hospital · 131d
Cleared Feb 04, 2002
ADVANCED AIR PURIFICATION SYSTEM
K012549
Healthway Products, Inc.
General Hospital · 181d
Cleared Mar 28, 2001
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
K010616
Hmi Industries, Inc.
General Hospital · 27d
Cleared Nov 17, 2000
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
K002692
Hmi Industries, Inc.
General Hospital · 80d
Cleared Jun 24, 1999
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
K984116
Abatement Technologies, Inc.
General Hospital · 219d
Cleared Oct 13, 1998
BREATHE EASY, MODELS AD AND CD
K981841
Respiraid , Ltd.
General Hospital · 140d
Cleared Jan 23, 1998
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682
Biological Controls, Inc.
General Hospital · 39d
Cleared Jan 10, 1997
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
K960966
Sunbeam-Oster Household Products
General Hospital · 305d
Cleared Nov 28, 1994
NORELCO CLEAN AIR SYSTEM CAS950
K945161
Hogan & Hartson
General Hospital · 42d
Cleared Sep 15, 1976
FILTER, PARTICULATE ARRESTING
K760481
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 4 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 →