FDA Product Code
FDA Product Code FRF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5045
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | 2025-11-14 | Traditional | PDF ↗ |
| K242102 | CerroZone Mini | Cerrozone, LLC | 2024-11-19 | Traditional | PDF ↗ |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 | Special | PDF ↗ |
| K223835 | MA-40, MA-112 | Medify Air, LLC | 2023-09-18 | Traditional | PDF ↗ |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | 2023-05-01 | Traditional | PDF ↗ |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | 2022-11-22 | Traditional | PDF ↗ |
| K220990 | Qorda QD1 | Winix, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K220298 | CerroZone Mobile | Cerrozone | 2022-07-01 | Traditional | PDF ↗ |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020-12-28 | Traditional | PDF ↗ |
| K130702 | AIRSONETT AIR-4 | Airsonett AB | 2013-07-23 | Traditional | PDF ↗ |
| K112728 | HEPAIRX VENTILATING AIR PURIFIER | Air Innovations, Inc. | 2013-01-23 | Traditional | PDF ↗ |
| K081062 | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | 2008-03-27 | Traditional | PDF ↗ |
| K070722 | PLASMAIR, MODEL T2006 | Airinspace B.V. | 2007-12-14 | Traditional | PDF ↗ |
| K023693 | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Airex, Inc. | 2003-03-12 | Traditional | PDF ↗ |
| K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Healthway Products, Inc. | 2002-02-04 | Traditional | PDF ↗ |
| K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | 2001-03-28 | Special | PDF ↗ |
| K002692 | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Hmi Industries, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K984116 | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C | Abatement Technologies, Inc. | 1999-06-24 | Traditional | PDF ↗ |
| K981841 | BREATHE EASY, MODELS AD AND CD | Respiraid , Ltd. | 1998-10-13 | Traditional | PDF ↗ |
| K974682 | MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP | Biological Controls, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K960966 | HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 | Sunbeam-Oster Household Products | 1997-01-10 | Traditional | PDF ↗ |
| K953536 | SLANT/FIN HEPA CLEAR | Amcor, Ltd. | 1995-10-30 | Traditional | PDF ↗ |
| K944305 | FRIEDRICH ELECTRONIC AIR CLEANER | Friedrich Air Conditioning Co., Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K930521 | AIR CLEANERS WITH HEPA FILTRATION | The Rival Co. | 1995-06-16 | Traditional | PDF ↗ |
| K942434 | BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER | Bionaire Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K945161 | NORELCO CLEAN AIR SYSTEM CAS950 | Hogan & Hartson | 1994-11-28 | Traditional | PDF ↗ |
| K943238 | NORELCO CLEAN AIR SYSTEM | Philips Electronic North America Corp. (Pena) | 1994-11-28 | Traditional | PDF ↗ |
| K944927 | NORELCO CLEAN AIR SYSTEM CAS900 | Norelco Consumer Products Co. | 1994-11-28 | Traditional | PDF ↗ |
| K942683 | BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 | Bionaire Corp. | 1994-11-28 | Traditional | PDF ↗ |
| K942512 | PA300 | The Rival Co. | 1994-11-18 | Traditional | PDF ↗ |
| K942686 | NORELCO CLEAN AIR SYSTEM MODEL CAM665 | Norelco Consumer Products Co. | 1994-10-07 | Traditional | PDF ↗ |
| K940573 | HEPA AIR CLEANER | Duracraft Corp. | 1994-08-25 | Traditional | PDF ↗ |
| K925055 | POLLENEX HEPA AIR CLEANERS | Pollenex Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K925566 | HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300 | Holmes Products Corp. | 1994-03-17 | Traditional | PDF ↗ |
| K930860 | HEPA 2500 AIR CLEANER | Trion, Inc. | 1993-12-22 | Traditional | PDF ↗ |
| K930420 | HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 | Hunter Fan Co. | 1993-09-23 | Traditional | PDF ↗ |
| K884472 | AIR-ELECTRONIC AIR CLEANER (FILTER) | White-Rodgers, Div. Emerson Electric Co. | 1989-01-19 | Traditional | PDF ↗ |
| K872359 | ENVIRACAIRE MODEL EV-1 | Enviracaire Corp. | 1987-12-07 | Traditional | PDF ↗ |
| K862432 | HEPACRON PUREAIR-ZONE SYSTEM | Hepacron, Inc. | 1986-10-16 | Traditional | PDF ↗ |
| K861299 | HYGIENIC AIR PURIFYING DEVICE | Puridyne, Inc./Imutech, Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K854817 | INSTAPURE | Teledyne, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Medicor USA , Ltd. | 1985-07-01 | Traditional | PDF ↗ |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Medicor USA , Ltd. | 1985-06-19 | Traditional | PDF ↗ |
| K843435 | LABMASTER & CRSI 600 | Control Resource Systems, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K842973 | HAYFEVER HELMET | R.H. Hinchli Fle & Sons, Ltd. | 1984-10-25 | Traditional | PDF ↗ |
| K831067 | BREATHING ZONE | Upper Four, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K812320 | AIR ALIVE | Western Systems, Inc. | 1982-02-24 | Traditional | PDF ↗ |
| K813258 | ULTIMATE-AIRE | Hawkins Intl. | 1982-02-05 | Traditional | PDF ↗ |
| K812656 | DOTRICH ELECTRONIC AIR CLEANER #C500AM | Leedal, Inc. | 1981-10-08 | Traditional | PDF ↗ |
| K760921 | AIR PURIFIER | Vitaire Corp. | 1976-12-29 | Traditional | PDF ↗ |
| K760879 | ROOM AIR PURIFIER (TEX-DYN) | Texas Dynamics | 1976-12-16 | Traditional | PDF ↗ |
| K760481 | FILTER, PARTICULATE ARRESTING | Miles Laboratories, Inc. | 1976-09-15 | Traditional | PDF ↗ |
Product code FRF · Class II · General Hospital. Data: openFDA.