Product Code: FRF FDA class 2 21 CFR 880.5045

Cleaner, Air, Medical Recirculating

General Hospital

A medical recirculating air cleaner is a device used in healthcare settings to filter and recirculate room air, removing particulate matter and potentially infectious aerosols. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is FRF, regulated under 21 CFR 880.5045, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FRF
Device Class: FDA class 2
Regulation Number: 880.5045
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

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