Panels › General Hospital › Product code FRF · Class 2
Cleaner, Air, Medical Recirculating
Regulation 880.5045
1510(k)s in 12 months (53 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Airsonett AB | 2 | 0 |
| Bionaire Corp. | 2 | 0 |
| Cerrozone | 2 | 0 |
| Hmi Industries, Inc. | 2 | 0 |
| Medicor USA , Ltd. | 2 | 0 |
| Norelco Consumer Products Co. | 2 | 0 |
| The Rival Co. | 2 | 0 |
| Abatement Technologies, Inc. | 1 | 0 |
| Air Innovations, Inc. | 1 | 0 |
| Airex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2025 | K251872 | Biomoneta Avata Rx Biomoneta Research Private Limited, IN | FRF |
| Nov 19, 2024 | K242102 | CerroZone Mini Cerrozone, LLC | FRF |
| Jun 14, 2024 | K240696 | Airdog X8 Air Purifier (KJ800F-X8) Suzhou Beiang Smart Technology Co., Ltd., CN | FRF |
| Sep 18, 2023 | K223835 | MA-40, MA-112 Medify Air, LLC | FRF |
| May 1, 2023 | K222416 | RIA Safeguard Ria Tech Co., Ltd., TW | FRF |
| Nov 22, 2022 | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) Beiang Air Tech , Ltd., CN | FRF |
| Sep 14, 2022 | K220990 | Qorda QD1 Winix, Inc., KR | FRF |
| Jul 1, 2022 | K220298 | CerroZone Mobile Cerrozone | FRF |
| Dec 28, 2020 | K200321 | Novaerus NV1050 Novaerus Us, Inc. | FRF |
| Jul 23, 2013 | K130702 | AIRSONETT AIR-4 Airsonett AB | FRF |
| Jan 23, 2013 | K112728 | HEPAIRX VENTILATING AIR PURIFIER Air Innovations, Inc. | FRF |
| Nov 7, 2008 | K081062 | AIRSONNETT AIRSHOWER AIR 3 Airsonett, Inc. | FRF |
| Mar 27, 2008 | K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 Airistar Technologies, LLC | FRF |
| Dec 14, 2007 | K070722 | PLASMAIR, MODEL T2006 Airinspace B.V. | FRF |
| Mar 12, 2003 | K023693 | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 Airex, Inc. | FRF |
| Feb 4, 2002 | K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM Healthway Products, Inc. | FRF |
| Mar 28, 2001 | K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A Hmi Industries, Inc. | FRF |
| Nov 17, 2000 | K002692 | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A Hmi Industries, Inc. | FRF |
| Jun 24, 1999 | K984116 | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C Abatement Technologies, Inc. | FRF |
| Oct 13, 1998 | K981841 | BREATHE EASY, MODELS AD AND CD Respiraid , Ltd., IL | FRF |
| Jan 23, 1998 | K974682 | MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP Biological Controls, Inc. | FRF |
| Jan 10, 1997 | K960966 | HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 Sunbeam-Oster Household Products | FRF |
| Oct 30, 1995 | K953536 | SLANT/FIN HEPA CLEAR Amcor, Ltd. | FRF |
| Aug 28, 1995 | K944305 | FRIEDRICH ELECTRONIC AIR CLEANER Friedrich Air Conditioning Co., Inc. | FRF |
| Jun 16, 1995 | K930521 | AIR CLEANERS WITH HEPA FILTRATION The Rival Co. | FRF |
| Dec 14, 1994 | K942434 | BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER Bionaire Corp., CA | FRF |
| Nov 28, 1994 | K945161 | NORELCO CLEAN AIR SYSTEM CAS950 Hogan & Hartson | FRF |
| Nov 28, 1994 | K944927 | NORELCO CLEAN AIR SYSTEM CAS900 Norelco Consumer Products Co. | FRF |
| Nov 28, 1994 | K943238 | NORELCO CLEAN AIR SYSTEM Philips Electronic North America Corp. (Pena) | FRF |
| Nov 28, 1994 | K942683 | BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 Bionaire Corp., CA | FRF |
| Nov 18, 1994 | K942512 | PA300 The Rival Co. | FRF |
| Oct 7, 1994 | K942686 | NORELCO CLEAN AIR SYSTEM MODEL CAM665 Norelco Consumer Products Co. | FRF |
| Aug 25, 1994 | K940573 | HEPA AIR CLEANER Duracraft Corp. | FRF |
| May 18, 1994 | K925055 | POLLENEX HEPA AIR CLEANERS Pollenex Corp. | FRF |
| Mar 17, 1994 | K925566 | HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300 Holmes Products Corp. | FRF |
| Dec 22, 1993 | K930860 | HEPA 2500 AIR CLEANER Trion, Inc. | FRF |
| Sep 23, 1993 | K930420 | HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 Hunter Fan Co. | FRF |
| Jan 19, 1989 | K884472 | AIR-ELECTRONIC AIR CLEANER (FILTER) White-Rodgers, Div. Emerson Electric Co. | FRF |
| Dec 7, 1987 | K872359 | ENVIRACAIRE MODEL EV-1 Enviracaire Corp. | FRF |
| Oct 16, 1986 | K862432 | HEPACRON PUREAIR-ZONE SYSTEM Hepacron, Inc. | FRF |
| Jul 23, 1986 | K861299 | HYGIENIC AIR PURIFYING DEVICE Puridyne, Inc./Imutech, Inc. | FRF |
| Feb 28, 1986 | K854817 | INSTAPURE Teledyne, Inc. | FRF |
| Jul 1, 1985 | K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER Medicor USA , Ltd. | FRF |
| Jun 19, 1985 | K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER Medicor USA , Ltd. | FRF |
| May 15, 1985 | K843435 | LABMASTER & CRSI 600 Control Resource Systems, Inc. | FRF |
| Oct 25, 1984 | K842973 | HAYFEVER HELMET R.H. Hinchli Fle & Sons, Ltd. | FRF |
| Jun 16, 1983 | K831067 | BREATHING ZONE Upper Four, Inc. | FRF |
| Feb 24, 1982 | K812320 | AIR ALIVE Western Systems, Inc. | FRF |
| Feb 5, 1982 | K813258 | ULTIMATE-AIRE Hawkins Intl. | FRF |
| Oct 8, 1981 | K812656 | DOTRICH ELECTRONIC AIR CLEANER #C500AM Leedal, Inc. | FRF |
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