Atlas FDA

FRF

53 FDA 510(k) clearances · Product code

149 daysmedian time to decision
360 days90th percentile
53clearances measured

FDA profile

Official device name
Cleaner, Air, Medical Recirculating
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5045
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 3 · 2001: 3 · 2002: 1 · 2003: 3 · 2007: 2 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Biomoneta Avata Rx (K251872)Biomoneta Research Private Limited2025-11-14
CerroZone Mini (K242102)Cerrozone, LLC2024-11-19
Airdog X8 Air Purifier (KJ800F-X8) (K240696)Suzhou Beiang Smart Technology Co., Ltd.2024-06-14
MA-40, MA-112 (K223835)Medify Air, LLC2023-09-18
RIA Safeguard (K222416)Ria Tech Co., Ltd.2023-05-01
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (K211507)Beiang Air Tech , Ltd.2022-11-22
Qorda QD1 (K220990)Winix, Inc.2022-09-14
CerroZone Mobile (K220298)Cerrozone2022-07-01
Novaerus NV1050 (K200321)Novaerus Us, Inc.2020-12-28
AIRSONETT AIR-4 (K130702)Airsonett AB2013-07-23
HEPAIRX VENTILATING AIR PURIFIER (K112728)Air Innovations, Inc.2013-01-23
AIRSONNETT AIRSHOWER AIR 3 (K081062)Airsonett, Inc.2008-11-07
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 (K072185)Airistar Technologies, LLC2008-03-27
PLASMAIR, MODEL T2006 (K070722)Airinspace B.V.2007-12-14
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 (K023693)Airex, Inc.2003-03-12
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM (K012549)Healthway Products, Inc.2002-02-04
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A (K010616)Hmi Industries, Inc.2001-03-28
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A (K002692)Hmi Industries, Inc.2000-11-17
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C (K984116)Abatement Technologies, Inc.1999-06-24
BREATHE EASY, MODELS AD AND CD (K981841)Respiraid , Ltd.1998-10-13
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP (K974682)Biological Controls, Inc.1998-01-23
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 (K960966)Sunbeam-Oster Household Products1997-01-10
SLANT/FIN HEPA CLEAR (K953536)Amcor, Ltd.1995-10-30
FRIEDRICH ELECTRONIC AIR CLEANER (K944305)Friedrich Air Conditioning Co., Inc.1995-08-28
AIR CLEANERS WITH HEPA FILTRATION (K930521)The Rival Co.1995-06-16
BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER (K942434)Bionaire Corp.1994-12-14
NORELCO CLEAN AIR SYSTEM (K943238)Philips Electronic North America Corp. (Pena)1994-11-28
NORELCO CLEAN AIR SYSTEM CAS900 (K944927)Norelco Consumer Products Co.1994-11-28
NORELCO CLEAN AIR SYSTEM CAS950 (K945161)Hogan & Hartson1994-11-28
BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 (K942683)Bionaire Corp.1994-11-28
PA300 (K942512)The Rival Co.1994-11-18
NORELCO CLEAN AIR SYSTEM MODEL CAM665 (K942686)Norelco Consumer Products Co.1994-10-07
HEPA AIR CLEANER (K940573)Duracraft Corp.1994-08-25
POLLENEX HEPA AIR CLEANERS (K925055)Pollenex Corp.1994-05-18
HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300 (K925566)Holmes Products Corp.1994-03-17
HEPA 2500 AIR CLEANER (K930860)Trion, Inc.1993-12-22
HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 (K930420)Hunter Fan Co.1993-09-23
AIR-ELECTRONIC AIR CLEANER (FILTER) (K884472)White-Rodgers, Div. Emerson Electric Co.1989-01-19
ENVIRACAIRE MODEL EV-1 (K872359)Enviracaire Corp.1987-12-07
HEPACRON PUREAIR-ZONE SYSTEM (K862432)Hepacron, Inc.1986-10-16
HYGIENIC AIR PURIFYING DEVICE (K861299)Puridyne, Inc./Imutech, Inc.1986-07-23
INSTAPURE (K854817)Teledyne, Inc.1986-02-28
MODEL BION 2/TYPE 90 ROOM IONIZER (K851358)Medicor USA , Ltd.1985-07-01
MODEL BION 1/TYPE 1084T CAR IONIZER (K851094)Medicor USA , Ltd.1985-06-19
LABMASTER & CRSI 600 (K843435)Control Resource Systems, Inc.1985-05-15
HAYFEVER HELMET (K842973)R.H. Hinchli Fle & Sons, Ltd.1984-10-25
BREATHING ZONE (K831067)Upper Four, Inc.1983-06-16
AIR ALIVE (K812320)Western Systems, Inc.1982-02-24
ULTIMATE-AIRE (K813258)Hawkins Intl.1982-02-05
DOTRICH ELECTRONIC AIR CLEANER #C500AM (K812656)Leedal, Inc.1981-10-08
AIR PURIFIER (K760921)Vitaire Corp.1976-12-29
ROOM AIR PURIFIER (TEX-DYN) (K760879)Texas Dynamics1976-12-16
FILTER, PARTICULATE ARRESTING (K760481)Miles Laboratories, Inc.1976-09-15

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