Purifier, Air, Ultraviolet, Medical

FDA product code FRA · 35 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6500
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1987-01-13 – 2025-09-15

FRA 2025-09-15

Zener® (model ZEN-001-B1)

Applicant Uvx, Inc.

K number K252128

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FRA 2024-08-01

ViroZap Indoor Air Purifier, In Duct Model 1008

Applicant Applied Photonix, LLC

K number K241140

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FRA 2024-05-23

AirKEE T900

Applicant Healkee Medical Pte, Ltd.

K number K232642

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FRA 2024-05-16

AirKEE P900

Applicant Healkee Medical Pte, Ltd.

K number K232933

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FRA 2024-02-16

Airgle Room Air Purifier

Applicant Airgle Corporation

K number K232645

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FRA 2023-06-14

Synexis Sphere Rx

Applicant Synexis, LLC

K number K221540

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FRA 2023-06-02

RGS; RGS Mini

Applicant Genesis Air, Inc.

K number K222702

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FRA 2022-11-30

Purgo

Applicant Aeroclean Technologies, Inc.

K number K223328

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FRA 2022-06-01

Purgo

Applicant Aeroclean Technologies, LLC

K number K213753

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FRA 2022-05-26

Aura Storm

Applicant Invictus Lighting

K number K212644

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FRA 2022-02-17

Bluezone Model RX-450 Air Purifier

Applicant Bluezone Products, Inc.

K number K212824

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FRA 2021-11-26

CUBE Air Purifier

Applicant Samsung Electronics Co., Ltd.

K number K211139

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FRA 2021-08-20

Molekule Air Pro

Applicant Molekule, Inc.

K number K211194

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FRA 2021-06-11

EOS Air Cleaner

Applicant Guangzhou Ajax Medical Equipment Co., Ltd.

K number K202766

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FRA 2021-02-23

Molekule Air Mini, Molekule Air Mini +

Applicant Molekule, Inc.

K number K202339

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FRA 2021-01-21

AEROCURE-MD

Applicant Aerobiotix, Inc.

K number K203189

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FRA 2020-06-17

Aerus Medical Guardian,model F170A

Applicant Aerus Medical, LLC

K number K201220

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FRA 2020-04-15

Molekule Air Pro RX

Applicant Molekule, Inc.

K number K200500

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FRA 2017-02-08

Transformair Indoor Air Purifier

Applicant Transformair, LLC

K number K161468

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FRA 2006-10-27

ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

Applicant Eco-Rx, Inc.

K number K062716

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FRA 2006-02-24

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P

Applicant Abracair, Inc.

K number K052732

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FRA 2004-07-12

ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

Applicant John Mfg., Ltd.

K number K033448

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FRA 2003-02-04

AIROCIDE TI02

Applicant Kes Science & Technology, Inc.

K number K023830

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FRA 1999-04-02

SECOND WIND AIR PURIFIER

Applicant Monagan Ent., Inc.

K number K980745

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FRA 1997-12-01

MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV

Applicant Biological Controls, Inc.

K number K972064

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FRA 1996-10-28

VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM

Applicant Schiff & Co.

K number K954448

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FRA 1996-07-25

VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM

Applicant Uv Technologies, Inc.

K number K960833

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FRA 1995-10-12

RXAIR 3000

Applicant Clean Air Research & Development

K number K951981

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FRA 1995-02-14

VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE

Applicant Schiff & Co.

K number K943521

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FRA 1994-09-16

DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM

Applicant L&H Airco

K number K933454

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FRA 1994-05-12

CLESTRACLEAN(R) ROOM AIR PURIFIER

Applicant Clestra Cleanroom Technology, Inc.

K number K932803

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FRA 1994-04-13

ICS 9400 ULTRAVIOLET AIR PURIFIER

Applicant Medair, Inc.

K number K934914

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FRA 1993-04-07

STRAIGHT-LINES I.V. ORGANIZER

Applicant Taylor Bio-Medical, Inc.

K number K920965

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FRA 1988-12-12

UV AIR STERILIGHT

Applicant Allseasons Environmental Control, Inc.

K number K884579

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FRA 1987-01-13

AIR CARE AIR SANITIZER

Applicant Cooper-Hewitt Electric Co.

K number K860132

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