Product code FRF
- Device name
- Cleaner, Air, Medical Recirculating
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5045
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | 2025-11-14 |
| K242102 | CerroZone Mini | Cerrozone, LLC | 2024-11-19 |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 |
| K223835 | MA-40, MA-112 | Medify Air, LLC | 2023-09-18 |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | 2023-05-01 |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | 2022-11-22 |
| K220990 | Qorda QD1 | Winix, Inc. | 2022-09-14 |
| K220298 | CerroZone Mobile | Cerrozone | 2022-07-01 |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020-12-28 |
| K130702 | AIRSONETT AIR-4 | Airsonett AB | 2013-07-23 |
| K112728 | HEPAIRX VENTILATING AIR PURIFIER | Air Innovations, Inc. | 2013-01-23 |
| K081062 | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | 2008-11-07 |
| K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | 2008-03-27 |
| K070722 | PLASMAIR, MODEL T2006 | Airinspace B.V. | 2007-12-14 |
| K023693 | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Airex, Inc. | 2003-03-12 |
| K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Healthway Products, Inc. | 2002-02-04 |
| K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | 2001-03-28 |
| K002692 | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Hmi Industries, Inc. | 2000-11-17 |
| K984116 | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C | Abatement Technologies, Inc. | 1999-06-24 |
| K981841 | BREATHE EASY, MODELS AD AND CD | Respiraid , Ltd. | 1998-10-13 |
| K974682 | MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP | Biological Controls, Inc. | 1998-01-23 |
| K960966 | HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 | Sunbeam-Oster Household Products | 1997-01-10 |
| K953536 | SLANT/FIN HEPA CLEAR | Amcor, Ltd. | 1995-10-30 |
| K944305 | FRIEDRICH ELECTRONIC AIR CLEANER | Friedrich Air Conditioning Co., Inc. | 1995-08-28 |
| K930521 | AIR CLEANERS WITH HEPA FILTRATION | The Rival Co. | 1995-06-16 |
| K942434 | BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER | Bionaire Corp. | 1994-12-14 |
| K945161 | NORELCO CLEAN AIR SYSTEM CAS950 | Hogan & Hartson | 1994-11-28 |
| K944927 | NORELCO CLEAN AIR SYSTEM CAS900 | Norelco Consumer Products Co. | 1994-11-28 |
| K943238 | NORELCO CLEAN AIR SYSTEM | Philips Electronic North America Corp. (Pena) | 1994-11-28 |
| K942683 | BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 | Bionaire Corp. | 1994-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07350128750015 | Airsonett AIR-4 | Airsonett AB | 2023-02-01 |
| 07350128750022 | Airsonett AIR-4 A-1100 | Airsonett AB | 2023-02-01 |
| 07290018896235 | SU-VEID | ANGIE TECHNOLOGIES LTD | 2021-05-23 |
| 00863342000318 | Defender | Health Mor At Home Cbp | 2021-03-11 |
| 00811095020015 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020022 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020077 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020084 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020138 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020152 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020169 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020176 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00811095020183 | RGF-BioControls | RGF ENVIRONMENTAL GROUP, INC. | 2020-03-09 |
| 00818261022019 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-02-26 |
| 00818261023504 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-29 |
| 00818261023207 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-29 |
| 00818261022903 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-29 |
| 00818261022309 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00818261021708 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00818261022002 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00818261021401 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00818261021104 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00818261022606 | HEPA-CARE® | ABATEMENT TECHNOLOGIES, INC. | 2020-01-15 |
| 00680418000016 | TRI-KLEEN | TRI-DIM FILTER CORPORATION | 2018-09-05 |
| 00680418000009 | TRI-KLEEN | TRI-DIM FILTER CORPORATION | 2018-09-05 |
| 00818261020510 | Hepa-Care® | ABATEMENT TECHNOLOGIES, INC. | 2018-06-12 |
| 00818261020206 | Hepa-Care® | ABATEMENT TECHNOLOGIES, INC. | 2017-09-05 |
| 00818261020305 | Hepa-Care® | ABATEMENT TECHNOLOGIES, INC. | 2017-09-05 |
| 00818261020312 | Hepa-Care® | ABATEMENT TECHNOLOGIES, INC. | 2017-08-11 |
| 00818261020503 | Hepa-Care® | ABATEMENT TECHNOLOGIES, INC. | 2017-08-11 |