Cleaner, Air, Medical Recirculating

FDA product code FRF · 53 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5045
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-09-15 – 2025-11-14

FRF 2025-11-14

Biomoneta Avata Rx

Applicant Biomoneta Research Private Limited

K number K251872

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FRF 2024-11-19

CerroZone Mini

Applicant Cerrozone, LLC

K number K242102

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FRF 2024-06-14

Airdog X8 Air Purifier (KJ800F-X8)

Applicant Suzhou Beiang Smart Technology Co., Ltd.

K number K240696

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FRF 2023-09-18

MA-40, MA-112

Applicant Medify Air, LLC

K number K223835

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FRF 2023-05-01

RIA Safeguard

Applicant Ria Tech Co., Ltd.

K number K222416

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FRF 2022-11-22

Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)

Applicant Beiang Air Tech , Ltd.

K number K211507

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FRF 2022-09-14

Qorda QD1

Applicant Winix, Inc.

K number K220990

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FRF 2022-07-01

CerroZone Mobile

Applicant Cerrozone

K number K220298

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FRF 2020-12-28

Novaerus NV1050

Applicant Novaerus Us, Inc.

K number K200321

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FRF 2013-07-23

AIRSONETT AIR-4

Applicant Airsonett AB

K number K130702

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FRF 2013-01-23

HEPAIRX VENTILATING AIR PURIFIER

Applicant Air Innovations, Inc.

K number K112728

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FRF 2008-11-07

AIRSONNETT AIRSHOWER AIR 3

Applicant Airsonett, Inc.

K number K081062

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FRF 2008-03-27

AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000

Applicant Airistar Technologies, LLC

K number K072185

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FRF 2007-12-14

PLASMAIR, MODEL T2006

Applicant Airinspace B.V.

K number K070722

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FRF 2003-03-12

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

Applicant Airex, Inc.

K number K023693

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FRF 2002-02-04

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM

Applicant Healthway Products, Inc.

K number K012549

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FRF 2001-03-28

DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

Applicant Hmi Industries, Inc.

K number K010616

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FRF 2000-11-17

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

Applicant Hmi Industries, Inc.

K number K002692

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FRF 1999-06-24

HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C

Applicant Abatement Technologies, Inc.

K number K984116

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FRF 1998-10-13

BREATHE EASY, MODELS AD AND CD

Applicant Respiraid , Ltd.

K number K981841

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FRF 1998-01-23

MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP

Applicant Biological Controls, Inc.

K number K974682

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FRF 1997-01-10

HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588

Applicant Sunbeam-Oster Household Products

K number K960966

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FRF 1995-10-30

SLANT/FIN HEPA CLEAR

Applicant Amcor, Ltd.

K number K953536

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FRF 1995-08-28

FRIEDRICH ELECTRONIC AIR CLEANER

Applicant Friedrich Air Conditioning Co., Inc.

K number K944305

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FRF 1995-06-16

AIR CLEANERS WITH HEPA FILTRATION

Applicant The Rival Co.

K number K930521

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FRF 1994-12-14

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER

Applicant Bionaire Corp.

K number K942434

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FRF 1994-11-28

NORELCO CLEAN AIR SYSTEM CAS950

Applicant Hogan & Hartson

K number K945161

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FRF 1994-11-28

NORELCO CLEAN AIR SYSTEM CAS900

Applicant Norelco Consumer Products Co.

K number K944927

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FRF 1994-11-28

NORELCO CLEAN AIR SYSTEM

Applicant Philips Electronic North America Corp. (Pena)

K number K943238

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FRF 1994-11-28

BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550

Applicant Bionaire Corp.

K number K942683

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FRF 1994-11-18

PA300

Applicant The Rival Co.

K number K942512

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FRF 1994-10-07

NORELCO CLEAN AIR SYSTEM MODEL CAM665

Applicant Norelco Consumer Products Co.

K number K942686

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FRF 1994-08-25

HEPA AIR CLEANER

Applicant Duracraft Corp.

K number K940573

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FRF 1994-05-18

POLLENEX HEPA AIR CLEANERS

Applicant Pollenex Corp.

K number K925055

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FRF 1994-03-17

HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300

Applicant Holmes Products Corp.

K number K925566

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FRF 1993-12-22

HEPA 2500 AIR CLEANER

Applicant Trion, Inc.

K number K930860

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FRF 1993-09-23

HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300

Applicant Hunter Fan Co.

K number K930420

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FRF 1989-01-19

AIR-ELECTRONIC AIR CLEANER (FILTER)

Applicant White-Rodgers, Div. Emerson Electric Co.

K number K884472

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FRF 1987-12-07

ENVIRACAIRE MODEL EV-1

Applicant Enviracaire Corp.

K number K872359

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FRF 1986-10-16

HEPACRON PUREAIR-ZONE SYSTEM

Applicant Hepacron, Inc.

K number K862432

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FRF 1986-07-23

HYGIENIC AIR PURIFYING DEVICE

Applicant Puridyne, Inc./Imutech, Inc.

K number K861299

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FRF 1986-02-28

INSTAPURE

Applicant Teledyne, Inc.

K number K854817

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FRF 1985-07-01

MODEL BION 2/TYPE 90 ROOM IONIZER

Applicant Medicor USA , Ltd.

K number K851358

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FRF 1985-06-19

MODEL BION 1/TYPE 1084T CAR IONIZER

Applicant Medicor USA , Ltd.

K number K851094

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FRF 1985-05-15

LABMASTER & CRSI 600

Applicant Control Resource Systems, Inc.

K number K843435

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FRF 1984-10-25

HAYFEVER HELMET

Applicant R.H. Hinchli Fle & Sons, Ltd.

K number K842973

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FRF 1983-06-16

BREATHING ZONE

Applicant Upper Four, Inc.

K number K831067

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FRF 1982-02-24

AIR ALIVE

Applicant Western Systems, Inc.

K number K812320

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FRF 1982-02-05

ULTIMATE-AIRE

Applicant Hawkins Intl.

K number K813258

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FRF 1981-10-08

DOTRICH ELECTRONIC AIR CLEANER #C500AM

Applicant Leedal, Inc.

K number K812656

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FRF 1976-12-29

AIR PURIFIER

Applicant Vitaire Corp.

K number K760921

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FRF 1976-12-16

ROOM AIR PURIFIER (TEX-DYN)

Applicant Texas Dynamics

K number K760879

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FRF 1976-09-15

FILTER, PARTICULATE ARRESTING

Applicant Miles Laboratories, Inc.

K number K760481

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