FRF — Cleaner, Air, Medical Recirculating Class II
FDA product code FRF covers "Cleaner, Air, Medical Recirculating", a Class II medical device regulated under 21 CFR 880.5045. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FRF
- Device Class
- Class II
- Regulation Number
- 880.5045
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251872 | Biomoneta Research Private Limited | Biomoneta Avata Rx | Nov 14, 2025 |
| K242102 | Cerrozone | CerroZone Mini | Nov 19, 2024 |
| K240696 | Suzhou Beiang Smart Technology Co | Airdog X8 Air Purifier (KJ800F-X8) | Jun 14, 2024 |
| K223835 | Medify Air | MA-40, MA-112 | Sep 18, 2023 |
| K222416 | Ria Tech Co | RIA Safeguard | May 1, 2023 |
| K211507 | Beiang Air Tech | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Nov 22, 2022 |
| K220990 | Winix | Qorda QD1 | Sep 14, 2022 |
| K220298 | Cerrozone | CerroZone Mobile | Jul 1, 2022 |
| K200321 | Novaerus Us | Novaerus NV1050 | Dec 28, 2020 |
| K130702 | Airsonett | AIRSONETT AIR-4 | Jul 23, 2013 |
| K112728 | Air Innovations | HEPAIRX VENTILATING AIR PURIFIER | Jan 23, 2013 |
| K081062 | Airsonett | AIRSONNETT AIRSHOWER AIR 3 | Nov 7, 2008 |
| K072185 | Airistar Technologies | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Mar 27, 2008 |
| K070722 | Airinspace | PLASMAIR, MODEL T2006 | Dec 14, 2007 |
| K023693 | Airex | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Mar 12, 2003 |
| K012549 | Healthway Products | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Feb 4, 2002 |
| K010616 | Hmi Industries | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Mar 28, 2001 |
| K002692 | Hmi Industries | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Nov 17, 2000 |
| K984116 | Abatement Technologies | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F… | Jun 24, 1999 |
| K981841 | Respiraid | BREATHE EASY, MODELS AD AND CD | Oct 13, 1998 |