Product Code: FRA FDA class 2 21 CFR 880.6500

Purifier, Air, Ultraviolet, Medical

General Hospital

A medical ultraviolet air purifier is a device that uses UV radiation to decontaminate air in healthcare environments, reducing airborne pathogens and improving infection control. 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 FRA, regulated under 21 CFR 880.6500, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: FRA
Device Class: FDA class 2
Regulation Number: 880.6500
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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252128	Zener® (model ZEN-001-B1)	Sep 15, 2025	Substantially Equivalent	Uvx, Inc.
K241140	ViroZap Indoor Air Purifier, In Duct Model 1008	Aug 01, 2024	Substantially Equivalent	Applied Photonix, LLC
K232642	AirKEE T900	May 23, 2024	Substantially Equivalent	Healkee Medical Pte, Ltd.
K232933	AirKEE P900	May 16, 2024	Substantially Equivalent	Healkee Medical Pte, Ltd.
K232645	Airgle Room Air Purifier	Feb 16, 2024	Substantially Equivalent	Airgle Corporation
K221540	Synexis Sphere Rx	Jun 14, 2023	Substantially Equivalent	Synexis, LLC
K222702	RGS; RGS Mini	Jun 02, 2023	Substantially Equivalent	Genesis Air, Inc.
K223328	Purgo	Nov 30, 2022	Substantially Equivalent	Aeroclean Technologies, Inc.
K213753	Purgo	Jun 01, 2022	Substantially Equivalent	Aeroclean Technologies, LLC
K212644	Aura Storm	May 26, 2022	Substantially Equivalent	Invictus Lighting
K212824	Bluezone Model RX-450 Air Purifier	Feb 17, 2022	Substantially Equivalent	Bluezone Products, Inc.
K211139	CUBE Air Purifier	Nov 26, 2021	Substantially Equivalent	Samsung Electronics Co., Ltd.
K211194	Molekule Air Pro	Aug 20, 2021	Substantially Equivalent	Molekule, Inc.
K202766	EOS Air Cleaner	Jun 11, 2021	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.
K202339	Molekule Air Mini, Molekule Air Mini +	Feb 23, 2021	Substantially Equivalent	Molekule, Inc.
K203189	AEROCURE-MD	Jan 21, 2021	Substantially Equivalent	Aerobiotix, Inc.
K201220	Aerus Medical Guardian,model F170A	Jun 17, 2020	Substantially Equivalent	Aerus Medical, LLC
K200500	Molekule Air Pro RX	Apr 15, 2020	Substantially Equivalent	Molekule, Inc.
K161468	Transformair Indoor Air Purifier	Feb 08, 2017	Substantially Equivalent	Transformair, LLC
K133800	ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI	Dec 19, 2014	Substantially Equivalent	Hgi Industires
K062716	ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400	Oct 27, 2006	Substantially Equivalent	Eco-Rx, Inc.
K052732	ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P	Feb 24, 2006	Substantially Equivalent	Abracair, Inc.
K033448	ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER	Jul 12, 2004	Substantially Equivalent	John Mfg., Ltd.
K023830	AIROCIDE TI02	Feb 04, 2003	Substantially Equivalent	Kes Science & Technology, Inc.
K980745	SECOND WIND AIR PURIFIER	Apr 02, 1999	Substantially Equivalent	Monagan Ent., Inc.
K972064	MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV	Dec 01, 1997	Substantially Equivalent	Biological Controls, Inc.
K954448	VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM	Oct 28, 1996	Substantially Equivalent	Schiff & Co.
K960833	VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM	Jul 25, 1996	Substantially Equivalent	Uv Technologies, Inc.
K951981	RXAIR 3000	Oct 12, 1995	Substantially Equivalent	Clean Air Research & Development
K943521	VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE	Feb 14, 1995	Substantially Equivalent	Schiff & Co.
K933454	DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM	Sep 16, 1994	Substantially Equivalent	L&H Airco
K932803	CLESTRACLEAN(R) ROOM AIR PURIFIER	May 12, 1994	Substantially Equivalent	Clestra Cleanroom Technology, Inc.
K934914	ICS 9400 ULTRAVIOLET AIR PURIFIER	Apr 13, 1994	Substantially Equivalent	Medair, Inc.
K920965	STRAIGHT-LINES I.V. ORGANIZER	Apr 07, 1993	Substantially Equivalent	Taylor Bio-Medical, Inc.
K884579	UV AIR STERILIGHT	Dec 12, 1988	Substantially Equivalent	Allseasons Environmental Control, Inc.
K860132	AIR CARE AIR SANITIZER	Jan 13, 1987	Substantially Equivalent	Cooper-Hewitt Electric Co.