FRF · Cleaner, Air, Medical Recirculating
General Hospital · 21 CFR 880.5045 · Class 2
Overview
| Product Code | FRF |
|---|---|
| Device Name | Cleaner, Air, Medical Recirculating |
| Regulation | 21 CFR 880.5045 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | Nov 14, 2025 | SESE |
| K242102 | CerroZone Mini | Cerrozone, LLC | Nov 19, 2024 | SESE |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | Jun 14, 2024 | SESE |
| K223835 | MA-40, MA-112 | Medify Air, LLC | Sep 18, 2023 | SESE |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | May 1, 2023 | SESE |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | Nov 22, 2022 | SESE |
| K220990 | Qorda QD1 | Winix, Inc. | Sep 14, 2022 | SESE |
| K220298 | CerroZone Mobile | Cerrozone | Jul 1, 2022 | SESE |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | Dec 28, 2020 | SESE |
| K130702 | AIRSONETT AIR-4 | Airsonett AB | Jul 23, 2013 | SESE |
| K112728 | HEPAIRX VENTILATING AIR PURIFIER | Air Innovations, Inc. | Jan 23, 2013 | SESE |
| K081062 | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | Nov 7, 2008 | SESE |
| K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | Mar 27, 2008 | SESE |
| K070722 | PLASMAIR, MODEL T2006 | Airinspace B.V. | Dec 14, 2007 | SESE |
| K023693 | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Airex, Inc. | Mar 12, 2003 | SESE |
| K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Healthway Products, Inc. | Feb 4, 2002 | SESE |
| K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | Mar 28, 2001 | SESE |
| K002692 | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Hmi Industries, Inc. | Nov 17, 2000 | SESE |
| K984116 | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C | Abatement Technologies, Inc. | Jun 24, 1999 | SESE |
| K981841 | BREATHE EASY, MODELS AD AND CD | Respiraid , Ltd. | Oct 13, 1998 | SESE |
Top Applicants
- Bionaire Corp. — 2 clearances
- Hmi Industries, Inc. — 2 clearances
- Medicor USA , Ltd. — 2 clearances
- Norelco Consumer Products Co. — 2 clearances
- The Rival Co. — 2 clearances
