Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5045](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5045) → FRF — Cleaner, Air, Medical Recirculating # FRF · Cleaner, Air, Medical Recirculating _General Hospital · 21 CFR 880.5045 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF ## Overview - **Product Code:** FRF - **Device Name:** Cleaner, Air, Medical Recirculating - **Regulation:** [21 CFR 880.5045](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5045) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K251872.md) | Biomoneta Avata Rx | Biomoneta Research Private Limited | Nov 14, 2025 | SESE | | [K242102](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K242102.md) | CerroZone Mini | Cerrozone, LLC | Nov 19, 2024 | SESE | | [K240696](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K240696.md) | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | Jun 14, 2024 | SESE | | [K223835](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K223835.md) | MA-40, MA-112 | Medify Air, LLC | Sep 18, 2023 | SESE | | [K222416](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K222416.md) | RIA Safeguard | Ria Tech Co., Ltd. | May 1, 2023 | SESE | | [K211507](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K211507.md) | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | Nov 22, 2022 | SESE | | [K220990](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K220990.md) | Qorda QD1 | Winix, Inc. | Sep 14, 2022 | SESE | | [K220298](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K220298.md) | CerroZone Mobile | Cerrozone | Jul 1, 2022 | SESE | | [K200321](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K200321.md) | Novaerus NV1050 | Novaerus Us, Inc. | Dec 28, 2020 | SESE | | [K130702](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K130702.md) | AIRSONETT AIR-4 | Airsonett AB | Jul 23, 2013 | SESE | | [K112728](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K112728.md) | HEPAIRX VENTILATING AIR PURIFIER | Air Innovations, Inc. | Jan 23, 2013 | SESE | | [K081062](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K081062.md) | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | Nov 7, 2008 | SESE | | [K072185](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K072185.md) | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | Mar 27, 2008 | SESE | | [K070722](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K070722.md) | PLASMAIR, MODEL T2006 | Airinspace B.V. | Dec 14, 2007 | SESE | | [K023693](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K023693.md) | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Airex, Inc. | Mar 12, 2003 | SESE | | [K012549](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K012549.md) | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Healthway Products, Inc. | Feb 4, 2002 | SESE | | [K010616](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K010616.md) | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | Mar 28, 2001 | SESE | | [K002692](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K002692.md) | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Hmi Industries, Inc. | Nov 17, 2000 | SESE | | [K984116](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K984116.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K981841.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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