Nebulizer (Direct Patient Interface)

FDA product code CAF · 492 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5630
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2026-09-18

CAF 2010-02-04

PARI VIOS

Applicant Pari Respiratory Equipment, Inc.

K number K092918

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CAF 2010-01-28

CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202

Applicant Steve Islava

K number K091794

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CAF 2009-12-02

RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

Applicant Instrumentation Industries, Inc.

K number K091111

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CAF 2009-11-13

AKITA JET

Applicant Activaero America, Inc.

K number K090730

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CAF 2009-11-10

BESMED JET NEBULIZER BOTTLE SET

Applicant Besmed Health Business Corp

K number K091272

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CAF 2009-10-09

SMARTTRACK SYSTEM

Applicant Nexus6, Ltd.

K number K091803

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CAF 2009-06-26

ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210

Applicant K-Jump Health Co., Ltd.

K number K083256

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CAF 2009-06-25

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.

Applicant Ventlab Corp.

K number K090840

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CAF 2009-06-18

DDI ULTRASONIC NEBULIZER SYSTEM

Applicant Diagnostic Devices, Inc.

K number K090307

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CAF 2009-04-09

AEROCHAMBER MINI VENTILATION CHAMBER

Applicant Trudell Medical Intl.

K number K090065

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CAF 2008-12-30

NEVONI CLASSIC, MODEL 6600-PO

Applicant Nsr Comercio E Representacoes Ltda

K number K082878

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CAF 2008-11-26

HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM

Applicant Medi Nuclear Corp., Inc.

K number K082541

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CAF 2008-10-23

AERONEB GO NEBULIZER

Applicant Aerogen (Ireland), Ltd.

K number K081650

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CAF 2008-09-17

ULTRASONIC NEBULIZER SYSTEM, MODEL HL100

Applicant Health & Life Co., Ltd.

K number K081738

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CAF 2008-08-22

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS

Applicant Hsiner Co., Ltd.

K number K082009

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CAF 2008-08-12

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

Applicant Trudell Medical Intl.

K number K080926

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CAF 2008-07-25

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510

Applicant Medi Nuclear Corp., Inc.

K number K080969

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CAF 2008-07-15

ULTRASONIC NEBULISER MODEL 2010

Applicant Wilfred Kromker GmbH

K number K072136

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CAF 2008-06-30

NEB-90 LARGE VOLUME MEDICATION NEBULIZER

Applicant Medi Nuclear Corp., Inc.

K number K080657

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CAF 2008-06-09

NEB-U-MASK SYSTEM, MODELS 1895, 1896

Applicant Teleflexmedical, Inc.

K number K080230

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CAF 2008-03-06

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5

Applicant 3A Health Care S.R.L.

K number K072163

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CAF 2008-02-12

AG-CLASSIC

Applicant Medel S.P.A.

K number K072494

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CAF 2007-12-28

AEROSOL SYSTEM

Applicant Amici, Inc.

K number K063716

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CAF 2007-12-13

MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER

Applicant Pari Innovative Manufacturers, Inc.

K number K072670

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CAF 2007-11-26

FUNHALER, MODEL V-201E

Applicant Infamed , Ltd.

K number K072822

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CAF 2007-11-05

AKITA2 APIXNEB

Applicant Activaero America, Inc.

K number K072019

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CAF 2007-10-01

AMSURE NEBULIZER

Applicant Amsino International, Inc.

K number K070411

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CAF 2007-09-12

OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER

Applicant Respironics New Jersey, Inc.

K number K072418

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CAF 2007-08-10

AIRLIFE NEBULIZER CAP

Applicant Cardinalhealth

K number K072119

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CAF 2007-06-08

FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS

Applicant Flaem Nuova S.P.A.

K number K062484

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CAF 2007-05-18

APEX MEDICAL MOBINEB, 9R-027 SERIES

Applicant Apex Medical Corp.

K number K070990

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CAF 2007-05-07

AERONEB PROFESSIONAL NEBULIZER SYSTEM

Applicant Aerogen (Ireland), Ltd.

K number K070642

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CAF 2007-04-26

HYPER SAL

Applicant Pari Innovative Manufacturers, Inc.

K number K070498

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CAF 2007-04-25

HSINER NEBULIZER BOTTLE

Applicant Hsiner

K number K070948

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CAF 2007-03-22

FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB

Applicant Flaem Nuova S.P.A.

K number K062014

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CAF 2007-03-01

DELUXE NEBULIZER

Applicant Access Point Medical, LLC

K number K063449

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CAF 2007-02-23

OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22

Applicant Omron Healthcare, Inc.

K number K062263

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CAF 2007-02-21

C300 SERIES AIR NEBULIZER COMPRESSOR

Applicant Choice Smart Health Care Co. , Ltd.

K number K062952

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CAF 2007-02-16

SIDESTREAM PLUS

Applicant Respironics , Ltd.

K number K062689

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CAF 2007-01-08

AG-EDGE, MODEL 91200

Applicant Medel S.P.A.

K number K063103

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CAF 2006-12-20

DPILOG, MODEL DPC-512

Applicant Life Outcomes, Inc.

K number K062811

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CAF 2006-08-28

LC SPRINT STAR

Applicant Pari Innovative Manufacturers, Inc.

K number K062158

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CAF 2006-07-24

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER

Applicant Merits Health Products Co., Ltd.

K number K053490

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CAF 2006-07-11

BABYAIR

Applicant Promedic, Inc.

K number K060497

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CAF 2006-06-22

AG-PLUS, MODEL 91210

Applicant Medel S.P.A.

K number K060404

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CAF 2006-06-21

REVJET TURBO

Applicant Promedic, Inc.

K number K060842

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CAF 2006-06-02

LC STAR WITH NASAL ADAPTER

Applicant Pari Innovative Manufacturers, Inc.

K number K061381

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CAF 2006-05-25

OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

Applicant Omron Healthcare, Inc.

K number K060811

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CAF 2006-04-05

TREK S NEBULIZER COMPRESSOR

Applicant Pari Innovative Manufacturers, Inc.

K number K060357

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CAF 2006-03-23

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C

Applicant Aerovectrx Corporation

K number K053360

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CAF 2006-03-02

LC SPRINT NEBULIZER

Applicant Pari Innovative Manufacturers, Inc.

K number K060399

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CAF 2006-02-27

AEROECLIPSE II BREATH ACTUATED NEBULIZER

Applicant Trudell Medical Intl.

K number K053605

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CAF 2006-01-31

EMG HANDLE NEBULIZER NB02 SERIES

Applicant Emg Technology Co., Ltd.

K number K052438

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CAF 2005-12-21

HSINER JET NEBULIZER, MODEL HS-31100

Applicant Hsiner Co., Ltd.

K number K052811

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CAF 2005-12-20

MYNEB NEBULIZER, MODEL RDD100

Applicant Respironics New Jersey, Inc.

K number K053203

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CAF 2005-12-09

I-NEB INSIGHT AAD SYSTEM

Applicant Profile Therapeutics Plc

K number K052941

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CAF 2005-09-23

I-NEB AAD SYSTEM

Applicant Profile Therapeutics Plc

K number K042991

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CAF 2005-09-15

SCHUCO MIST AND SCHUCO DELUXE MIST

Applicant Allied Healthcare Products, Inc.

K number K051260

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CAF 2005-08-16

SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES

Applicant Silvestrin Fabris S.R.L.

K number K050183

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CAF 2005-07-22

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321

Applicant K-Jump Health Co., Ltd.

K number K051365

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CAF 2005-07-06

COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES

Applicant Emg Technology Co., Ltd.

K number K043238

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CAF 2005-06-22

MD TURBO

Applicant Respirics, Inc.

K number K051284

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CAF 2005-02-16

APEX MEDICAL MININEB & MINIPLUS

Applicant Apex Medical Corp.

K number K050104

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CAF 2005-01-06

INVACARE PRO, COMPACT AND PORTABLE DESKTOP

Applicant Invacare Corporation

K number K042483

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CAF 2005-01-03

FUNHALER, MODEL FH 101

Applicant Infamed , Ltd.

K number K042546

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CAF 2004-10-13

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456

Applicant Respironics New Jersey, Inc.

K number K042655

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CAF 2004-09-28

GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103

Applicant Guan Hong Enterprise Co., Ltd.

K number K041079

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CAF 2004-09-07

NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER

Applicant Newport Medical Instruments, Inc.

K number K041082

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CAF 2004-09-01

SHINMED MODE SW-988 UNTRASONIC NEBULIZER

Applicant Shining World Health Care Co., Ltd.

K number K031370

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CAF 2004-07-20

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES

Applicant Med2000 S.R.L.

K number K041327

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CAF 2004-07-08

MDI TRIGGER GUARD

Applicant North American Technical Services (Nats) Corp.

K number K040439

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CAF 2004-06-10

AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

Applicant Cardinalhealth

K number K041418

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CAF 2004-05-28

TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000

Applicant Medical Industries America, Inc.

K number K032170

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CAF 2004-05-07

OMNI~NEB; OMNI~MAX

Applicant B&B Medical Technologies, Inc.

K number K030396

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CAF 2004-05-05

EFLOW ELECTRONIC INHALER/NEBULIZER

Applicant Pari Innovative Manufacturers, Inc.

K number K033833

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CAF 2004-04-22

PRODOSE AAD SYSTEM

Applicant Profile Therapeutics Plc

K number K030747

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CAF 2004-04-02

TRUST

Applicant Dhd Healthcare Corp.

K number K040718

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CAF 2004-04-02

BIRDSONG LEVERHALER, MODEL LH-1000

Applicant Birdsong Medical Devices, Inc.

K number K031982

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CAF 2004-03-04

HIOX80 AEROSOL ADAPTER

Applicant Sensor Medics Corp.

K number K032516

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CAF 2004-01-14

AEROCHAMBER MAX VALVED HOLDING CHAMBER

Applicant Trudell Medical Intl.

K number K032972

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CAF 2004-01-14

MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)

Applicant Med2000 S.R.L.

K number K031908

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CAF 2003-11-21

AERONEB GO NEBULIZER, MODEL AG-AG2000

Applicant Aerogen, Inc.

K number K032849

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CAF 2003-11-13

HOSPITAL SPACER

Applicant Respironics Healthscan, Inc.

K number K032809

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CAF 2003-08-25

SONIK LDI 20 AIR

Applicant Evit Labs, Inc.

K number K030374

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CAF 2003-05-01

SMALL VOLUME NEBULIZER

Applicant Allegiance Healthcare Corporation

K number K023602

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CAF 2002-10-25

GALEMED NEB-EASY NEBULIZER

Applicant Galemed Corp.

K number K021742

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CAF 2002-10-21

56 SERIES JET NEBULIZER

Applicant Project Marketing

K number K021443

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CAF 2002-08-07

800 SERIES EASYNEB NEBULIZER

Applicant Nellcor Puritan Bennett, Inc.

K number K020357

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CAF 2002-06-28

DEVILBISS PULMO-AIDE COMPACT COMPRESSOR

Applicant Sunrise Medical

K number K020932

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CAF 2002-05-15

AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000

Applicant Aerogen, Inc.

K number K021175

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CAF 2002-05-09

VORTEX VALVED HOLDING CHAMBER

Applicant Pari Innovative Manufacturers, Inc.

K number K020944

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CAF 2002-02-01

SALTER LABS MODIFIED NEBUTECH NEBULIZER

Applicant Salter Labs

K number K014056

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CAF 2001-09-28

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER

Applicant Monaghan Medical Corp.

K number K012939

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CAF 2001-07-13

MEDICAL DEPOT POWER NEB 1

Applicant Medical Depot, Inc.

K number K012006

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CAF 2001-06-14

COMOACT ULTRASONIC NEBULIZER, MODEL 3060

Applicant San UP S.A.

K number K002543

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CAF 2001-05-23

CT SPACER

Applicant Clinical Technologies, Inc.

K number K010680

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CAF 2001-05-23

VEGA ULTRASONIC NEBULIZER

Applicant Vega Technologies, Inc.

K number K002831

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CAF 2001-03-15

MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2

Applicant Medical Depot, Inc.

K number K003344

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CAF 2001-03-13

ULTRASONIC NEBULIZER, MODEL NE-520

Applicant Medisana USA, Inc.

K number K002153

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CAF 2000-10-26

LITEAIRE

Applicant Thayer Medical Corp.

K number K993101

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