Cleaner, Air, Medical Recirculating
FDA product code FRF · Class II (moderate risk) · 21 CFR 880.5045 · General Hospital
53510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Norelco Consumer Products Co. 2
- The Rival Co. 2
- Bionaire Corp. 2
- Hmi Industries, Inc. 2
- Airsonett AB 2
- Medicor USA , Ltd. 2
- Cerrozone 2
- Teledyne, Inc. 1
- Holmes Products Corp. 1
- Hunter Fan Co. 1
- White-Rodgers, Div. Emerson Electric Co. 1
- Enviracaire Corp. 1
- Hepacron, Inc. 1
- Puridyne, Inc./Imutech, Inc. 1
- R.H. Hinchli Fle & Sons, Ltd. 1
- Biomoneta Research Private Limited 1
- Western Systems, Inc. 1
- Hawkins Intl. 1
- Leedal, Inc. 1
- Vitaire Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251872 | Biomoneta Avata RxFRF · Traditional | Biomoneta Research Private Limited | 11/14/2025SE |
| K242102 | CerroZone MiniFRF · Traditional | Cerrozone, LLC | 11/19/2024SE |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8)FRF · Special | Suzhou Beiang Smart Technology Co., Ltd. | 06/14/2024SE |
| K223835 | MA-40, MA-112FRF · Traditional | Medify Air, LLC | 09/18/2023SE |
| K222416 | RIA SafeguardFRF · Traditional | Ria Tech Co., Ltd. | 05/01/2023SE |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)FRF · Traditional | Beiang Air Tech , Ltd. | 11/22/2022SE |
| K220990 | Qorda QD1FRF · Traditional | Winix, Inc. | 09/14/2022SE |
| K220298 | CerroZone MobileFRF · Traditional | Cerrozone | 07/01/2022SE |
| K200321 | Novaerus NV1050FRF · Traditional | Novaerus Us, Inc. | 12/28/2020SE |
| K130702 | Airsonett AIR-4FRF · Traditional | Airsonett AB | 07/23/2013SE |
| K112728 | Hepairx Ventilating Air PurifierFRF · Traditional | Air Innovations, Inc. | 01/23/2013SE |
| K081062 | Airsonnett Airshower Air 3FRF · Traditional | Airsonett, Inc. | 11/07/2008SE |
| K072185 | Airistar Air Purification System, Model 500 & 1000FRF · Traditional | Airistar Technologies, LLC | 03/27/2008SE |
| K070722 | Plasmair, Model T2006FRF · Traditional | Airinspace B.V. | 12/14/2007SE |
| K023693 | Mobile Particulate Contamination Control System, Model M-100FRF · Traditional | Airex, Inc. | 03/12/2003SE |
| K012549 | Advanced Air Purification System; Hepa Air Cleaning SystemFRF · Traditional | Healthway Products, Inc. | 02/04/2002SE |
| K010616 | Defender Room Air Cleaner, Model RAC-4000AFRF · Special | Hmi Industries, Inc. | 03/28/2001SE |
| K002692 | Defender Room Air Cleaner, Model RAC-3000AFRF · Traditional | Hmi Industries, Inc. | 11/17/2000SE |
| K984116 | Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F…FRF · Traditional | Abatement Technologies, Inc. | 06/24/1999SE |
| K981841 | Breathe Easy, Models Ad and CDFRF · Traditional | Respiraid , Ltd. | 10/13/1998SE |
| K974682 | Microcon 800M, Microcon 400M, Microcon Exc, Microcon Ex, Microcon WallmapFRF · Traditional | Biological Controls, Inc. | 01/23/1998SE |
| K960966 | Hepa-Type Air Cleaner Model 2586 and True Hepa Air Cleaner Models 2587 and 2588FRF · Traditional | Sunbeam-Oster Household Products | 01/10/1997SE |
| K953536 | Slant/Fin Hepa ClearFRF · Traditional | Amcor, Ltd. | 10/30/1995SE |
| K944305 | Friedrich Electronic Air CleanerFRF · Traditional | Friedrich Air Conditioning Co., Inc. | 08/28/1995SE |
| K930521 | Air Cleaners with Hepa FiltrationFRF · Traditional | The Rival Co. | 06/16/1995SE |
| K942434 | Bionaire Clear Air Air Purifier & IonizerFRF · Traditional | Bionaire Corp. | 12/14/1994SE |
| K945161 | Norelco Clean Air System CAS950FRF · Traditional | Hogan & Hartson | 11/28/1994SE |
| K944927 | Norelco Clean Air System CAS900FRF · Traditional | Norelco Consumer Products Co. | 11/28/1994SE |
| K943238 | Norelco Clean Air SystemFRF · Traditional | Philips Electronic North America Corp. (Pena) | 11/28/1994SE |
| K942683 | Bionaire Hepa Air Purifiers /SH-1240, 1260, 1840, 1860, CH-3550FRF · Traditional | Bionaire Corp. | 11/28/1994SE |
| K942512 | PA300FRF · Traditional | The Rival Co. | 11/18/1994SE |
| K942686 | Norelco Clean Air System Model CAM665FRF · Traditional | Norelco Consumer Products Co. | 10/07/1994SE |
| K940573 | Hepa Air CleanerFRF · Traditional | Duracraft Corp. | 08/25/1994SE |
| K925055 | Pollenex Hepa Air CleanersFRF · Traditional | Pollenex Corp. | 05/18/1994SE |
| K925566 | Holmes Air Purifier Models HAP-240 & HAP-300FRF · Traditional | Holmes Products Corp. | 03/17/1994SE |
| K930860 | Hepa 2500 Air CleanerFRF · Traditional | Trion, Inc. | 12/22/1993SE |
| K930420 | Hunter Air Cleaners Model Nos. 30100/30250/30300FRF · Traditional | Hunter Fan Co. | 09/23/1993SE |
| K884472 | Air-Electronic Air Cleaner (Filter)FRF · Traditional | White-Rodgers, Div. Emerson Electric Co. | 01/19/1989SE |
| K872359 | Enviracaire Model EV-1FRF · Traditional | Enviracaire Corp. | 12/07/1987SE |
| K862432 | Hepacron Pureair-Zone SystemFRF · Traditional | Hepacron, Inc. | 10/16/1986SE |
| K861299 | Hygienic Air Purifying DeviceFRF · Traditional | Puridyne, Inc./Imutech, Inc. | 07/23/1986SN |
| K854817 | InstapureFRF · Traditional | Teledyne, Inc. | 02/28/1986SE |
| K851358 | Model Bion 2/TYPE 90 Room IonizerFRF · Traditional | Medicor USA , Ltd. | 07/01/1985SE |
| K851094 | Model Bion 1/TYPE 1084T Car IonizerFRF · Traditional | Medicor USA , Ltd. | 06/19/1985SE |
| K843435 | Labmaster & Crsi 600FRF · Traditional | Control Resource Systems, Inc. | 05/15/1985SE |
| K842973 | Hayfever HelmetFRF · Traditional | R.H. Hinchli Fle & Sons, Ltd. | 10/25/1984SE |
| K831067 | Breathing ZoneFRF · Traditional | Upper Four, Inc. | 06/16/1983SE |
| K812320 | Air AliveFRF · Traditional | Western Systems, Inc. | 02/24/1982SE |
| K813258 | Ultimate-AireFRF · Traditional | Hawkins Intl. | 02/05/1982SE |
| K812656 | Dotrich Electronic Air Cleaner #C500AMFRF · Traditional | Leedal, Inc. | 10/08/1981SE |
| K760921 | Air PurifierFRF · Traditional | Vitaire Corp. | 12/29/1976SE |
| K760879 | Room Air Purifier (Tex-Dyn)FRF · Traditional | Texas Dynamics | 12/16/1976SE |
| K760481 | Filter, Particulate ArrestingFRF · Traditional | Miles Laboratories, Inc. | 09/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0933-2012 | Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next…The Company is recalling certain serial numbers of HealthWay Model 20600-3 and CleanStation Model CS20000… | Healthway Home Products, Inc. | 01/09/2012Terminated |