FRF — Cleaner, Air, Medical Recirculating Class II
FDA Device Classification
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 | November 14, 2025 |
| K242102 | cerrozone | CerroZone Mini | November 19, 2024 |
| K240696 | suzhou beiang smart technology co | Airdog X8 Air Purifier (KJ800F-X8) | June 14, 2024 |
| K223835 | medify air | MA-40, MA-112 | September 18, 2023 |
| K222416 | ria tech co | RIA Safeguard | May 1, 2023 |
| K211507 | beiang air tech | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | November 22, 2022 |
| K220990 | winix | Qorda QD1 | September 14, 2022 |
| K220298 | cerrozone | CerroZone Mobile | July 1, 2022 |
| K200321 | novaerus us | Novaerus NV1050 | December 28, 2020 |
| K130702 | airsonett | AIRSONETT AIR-4 | July 23, 2013 |
| K112728 | air innovations | HEPAIRX VENTILATING AIR PURIFIER | January 23, 2013 |
| K081062 | airsonett | AIRSONNETT AIRSHOWER AIR 3 | November 7, 2008 |
| K072185 | airistar technologies | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | March 27, 2008 |
| K070722 | airinspace | PLASMAIR, MODEL T2006 | December 14, 2007 |
| K023693 | airex | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | March 12, 2003 |
| K012549 | healthway products | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | February 4, 2002 |
| K010616 | hmi industries | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | March 28, 2001 |
| K002692 | hmi industries | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | November 17, 2000 |
| K984116 | abatement technologies | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, H | June 24, 1999 |
| K981841 | respiraid | BREATHE EASY, MODELS AD AND CD | October 13, 1998 |