FDA 510(k) Applications for Medical Device Product Code "CAF"
(Nebulizer (Direct Patient Interface))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072163 | 3A HEALTH CARE S.R.L. | HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 | 03/06/2008 |
| K063449 | ACCESS POINT MEDICAL, L.L.C. | DELUXE NEBULIZER | 03/01/2007 |
| K090730 | ACTIVAERO AMERICA, INC. | AKITA JET | 11/13/2009 |
| K072019 | ACTIVAERO AMERICA, INC. | AKITA2 APIXNEB | 11/05/2007 |
| K181405 | Adherium (NZ) Ltd | Hailie Sensor | 12/10/2018 |
| K182573 | Adherium (NZ) Ltd | Hailie Sensor | 06/07/2019 |
| K182638 | Adherium (NZ) Ltd | Hailie Sensor | 06/19/2019 |
| K220622 | Adherium (NZ) Ltd | Hailie Sensor NF0106 | 07/15/2022 |
| K221994 | Adherium (NZ) Ltd | Hailie Sensor NF0107 & NF0108 | 10/04/2022 |
| K211233 | Adherium (NZ) Ltd | Hailie Sensor NF0109 | 08/18/2021 |
| K222247 | Adherium (NZ) Ltd | Hailie Sensor NF0110 | 02/08/2023 |
| K180407 | Adherium (NZ) Ltd | Smartinhaler | 07/25/2018 |
| K163485 | Adherium (NZ) Ltd | SmartTouch | 08/30/2017 |
| K173310 | Adherium (NZ) Ltd | SmartTouch | 03/26/2018 |
| K081650 | AEROGEN (IRELAND) LTD | AERONEB GO NEBULIZER | 10/23/2008 |
| K070642 | AEROGEN (IRELAND) LTD | AERONEB PROFESSIONAL NEBULIZER SYSTEM | 05/07/2007 |
| K102240 | AEROGEN IRELAND, LTD. | NIVO NEBULIZER SYSTEM | 11/10/2010 |
| K143719 | Aerogen Limited | Aeroneb USB Contoller System | 07/10/2015 |
| K120939 | AEROGEN LTD | AERONEB PRO | 04/26/2012 |
| K133360 | AEROGEN LTD | AERONEB SOLO; AERONEB SOLO ADAPTER | 10/17/2014 |
| K103635 | AEROGEN LTD | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | 05/13/2011 |
| K232507 | Aerogen Ltd. | Aerogen«Solo Nebulizer System | 05/10/2024 |
| K032849 | AEROGEN, INC. | AERONEB GO NEBULIZER, MODEL AG-AG2000 | 11/21/2003 |
| K992831 | AEROGEN, INC. | AERONEB II, MODEL APN 200 | 08/25/2000 |
| K003022 | AEROGEN, INC. | AERONEB PORTABLE NEBULIZER | 10/13/2000 |
| K021175 | AEROGEN, INC. | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 | 05/15/2002 |
| K984085 | AEROMAX TECHNOLOGIES, INC. | RITEFLO SPACER | 08/05/1999 |
| K053360 | AEROVECTRX CORPORATION | AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C | 03/23/2006 |
| K201167 | AireHealth Inc. | AireHealth NebulizerTM | 12/03/2020 |
| K983002 | AIRSEP CORP. | MYSTIQUE ULTRASONIC NEBULIZER | 10/16/1998 |
| K023602 | ALLEGIANCE HEALTHCARE CORPORATION | SMALL VOLUME NEBULIZER | 05/01/2003 |
| K051260 | ALLIED HEALTHCARE PRODUCTS, INC. | SCHUCO MIST AND SCHUCO DELUXE MIST | 09/15/2005 |
| K982722 | AMBU, INC. | AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD | 04/12/1999 |
| K063716 | AMICI, INC. | AEROSOL SYSTEM | 12/28/2007 |
| K952910 | AMICI, INC. | THE SWIRLER NEBULIZER | 03/19/1997 |
| K070411 | AMSINO INTERNATIONAL, INC. | AMSURE NEBULIZER | 10/01/2007 |
| K050104 | APEX MEDICAL CORP. | APEX MEDICAL MININEB & MINIPLUS | 02/16/2005 |
| K070990 | APEX MEDICAL CORP. | APEX MEDICAL MOBINEB, 9R-027 SERIES | 05/18/2007 |
| K990435 | APEX MEDICAL CORP. | BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 | 06/05/2000 |
| K111246 | ARMSTRONG MEDICAL LTD. | SPIRALE DRUG DELIVERY SYSTEM | 08/10/2012 |
| K102719 | ATLANTEAN CORPORATION | ATLANTEAN TRIGGER NEBULIZER | 07/01/2011 |
| K955104 | AUTOMATIC LIQUID PACKAGING, INC. | HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER | 06/11/1996 |
| K980407 | B & B MEDICAL TECHNOLOGIES, INC. | HOPE NEBULIZER | 05/27/1998 |
| K030396 | B & B MEDICAL TECHNOLOGIES, INC. | OMNI~NEB; OMNI~MAX | 05/07/2004 |
| K962161 | BAXTER HEALTHCARE CORP. | BAXTER NEBULIZER CAP MODEL 2D0868 | 08/15/1996 |
| K091272 | BESMED HEALTH BUSINESS CORP. | BESMED JET NEBULIZER BOTTLE SET | 11/10/2009 |
| K150591 | BESMED HEALTH BUSINESS CORP. | Besmed Reusable Jet Nebulizer | 06/30/2015 |
| K031982 | BIRDSONG MEDICAL DEVICES INC | BIRDSONG LEVERHALER, MODEL LH-1000 | 04/02/2004 |
| K983736 | BRASAMERICA MEDICAL EQUIPMENT, INC. | ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER | 11/10/1998 |
| K972371 | BRASAMERICA MEDICAL EQUIPMENT, INC. | ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR | 08/19/1997 |
| K203155 | BreatheSuite Inc | BreatheSuite MDI V1 | 09/17/2021 |
| K982043 | BREMED ITALIA, S.R.L. | BRENEB | 11/09/1998 |
| K970542 | BREMED ITALIA, S.R.L. | MASTER NEB II | 06/24/1997 |
| K974379 | BREMED ITALIA, S.R.L. | ULTRANEB | 02/18/1998 |
| K041418 | Cardinal Health | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER | 06/10/2004 |
| K072119 | Cardinal Health | AIRLIFE NEBULIZER CAP | 08/10/2007 |
| K123527 | CAREFUSION | AIRLIFE | 04/25/2013 |
| K153748 | CareFusion | AirLife Misty Finity Nebulizer | 05/17/2017 |
| K062952 | CHOICE SMART HEALTH CARE CO. LTD. | C300 SERIES AIR NEBULIZER COMPRESSOR | 02/21/2007 |
| K010680 | CLINICAL TECHNOLOGIES, INC. | CT SPACER | 05/23/2001 |
| K183586 | Cognita Labs, LLC | CapMedic | 09/13/2019 |
| K000543 | CONTEMPORARY PRODUCTS, INC. | CONTEMPRO-MIST | 06/16/2000 |
| K964994 | CONTEMPORARY PRODUCTS, INC. | CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR | 02/21/1997 |
| K162041 | Convexity Scientific LLC | Airworks Nebulizer pe1200m | 05/02/2017 |
| K962874 | CURTIN & ASSOCIATES INTERNATIONAL , INC. | RESPIFLO/S | 02/25/1997 |
| K970289 | DEVILBISS HEALTH CARE, INC. | COMPRESSOR/NEBULIZER #3650 | 04/15/1997 |
| K952249 | DEVILBISS HEALTH CARE, INC. | JET NEBULIZER | 01/30/1996 |
| K972778 | DEY LABORATORIES, INC. | DEY VIAL SODIUM CHLORIDE 3% | 10/08/1997 |
| K961973 | DHD DIEMOLDING HEALTHCARE DIV. | DHD ACE WITH MASK KIT | 08/15/1996 |
| K973532 | DHD DIEMOLDING HEALTHCARE DIV. | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | 03/19/1998 |
| K981167 | DHD HEALTHCARE CORP. | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | 06/18/1998 |
| K040718 | DHD HEALTHCARE CORP. | TRUST | 04/02/2004 |
| K090307 | DIAGNOSTIC DEVICES, INC. | DDI ULTRASONIC NEBULIZER SYSTEM | 06/18/2009 |
| K133105 | DIGIO2 INTERNATIONAL CO., LTD | BREEZE NEBULIZER (NBR-10X) | 06/24/2014 |
| K123030 | DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C | COMPRESSOR NEBULIZER MODEL MCN-S600XX | 12/19/2013 |
| K230379 | Dongguan SIMZO Electronic Technology Co.Ltd. | Portable (Ultrasonic) Nebulizer | 11/27/2023 |
| K043238 | EMG TECHNOLOGY CO., LTD. | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | 07/06/2005 |
| K052438 | EMG TECHNOLOGY CO., LTD. | EMG HANDLE NEBULIZER NB02 SERIES | 01/31/2006 |
| K242354 | Enchant Tek Co. Ltd. | AllNEB | 04/29/2025 |
| K030374 | EVIT LABS, INC. | SONIK LDI 20 AIR | 08/25/2003 |
| K192971 | Excellentcare Medical (Huizhou) Ltd. | Nebulizer Kit | 07/08/2021 |
| K182906 | FeelLife Health Inc. | Portable Mesh Nebulizer | 09/27/2020 |
| K993199 | FERRARIS MEDICAL, INC. | POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER | 03/28/2000 |
| K992038 | FERRARIS MEDICAL, INC. | POCKETSPACER | 09/09/1999 |
| K211560 | Fisher & Paykel Healthcare Limited | Airvo Nebulizer Adapter | 12/10/2021 |
| K062014 | FLAEM NUOVA S.P.A. | FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB | 03/22/2007 |
| K062484 | FLAEM NUOVA S.P.A. | FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS | 06/08/2007 |
| K970010 | FLUID PROPULSION TECHNOLOGIES, INC. | FPT NEBULIZER | 04/01/1997 |
| K101552 | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 | 03/14/2011 |
| K132247 | FOSHAN GAUNYING ELECTRONICS CO., LTD. | ULTRASONIC MESH NEBULIZER | 01/08/2014 |
| K140211 | FOSHAN GAUNYING ELECTRONICS CO., LTD. | ULTRASONIC MESH NEBULIZER | 05/30/2014 |
| K121154 | FOSHAN GAUNYING ELECTRONICS CO., LTD. | ULTRASONIC NEBULIZER | 08/20/2012 |
| K021742 | GALEMED CORP. | GALEMED NEB-EASY NEBULIZER | 10/25/2002 |
| K952326 | GLOBAL MEDICAL ENT., INC. | PULMOMIST | 02/27/1996 |
| K192633 | Globalcare Medical Technology Co., Ltd. | GUS831 Compressor Nebulizer | 05/01/2020 |
| K970035 | GRAHAM-FIELD, INC. | JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 | 04/01/1997 |
| K041079 | GUAN HONG ENTERPRISE CO., LTD. | GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 | 09/28/2004 |
| K250583 | HCmed Innovations Co., Ltd. | AdheResp Smart Breath-actuated Mesh Nebulizer | 06/20/2025 |
| K202171 | HCMed Innovations Co., Ltd. | Pulmogine Vibrating Mesh Nebulizer | 07/01/2021 |
| K121770 | HEADSTAR MEDICAL PRODUCTS CO., LTD | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER | 04/17/2013 |
| K081738 | HEALTH & LIFE CO., LTD. | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 | 09/17/2008 |
| K963793 | HEALTHCARE PRODUCTS, INC. | OPTIVENT | 04/16/1997 |
| K960397 | HEALTHLINE MEDICAL | MEDICATOR AEROSOL DRUG DELIVERY SYSTEM | 04/26/1996 |
| K962822 | HEALTHSCAN PRODUCTS, INC. | OPTICHAMBER | 10/17/1996 |
| K963917 | HOLDEN WALKER CORP. | HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT | 02/25/1997 |
| K974056 | HOLOPACK INTERNATIONAL, LP | 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP | 01/21/1998 |
| K972466 | HOLOPACK INTERNATIONAL, LP | SODIUM CHLORIDE INHALATION SOLUTION, USP | 08/28/1997 |
| K972467 | HOLOPACK INTERNATIONAL, LP | STERILE WATER FOR INHALATION, USP | 08/28/1997 |
| K070948 | HSINER | HSINER NEBULIZER BOTTLE | 04/25/2007 |
| K052811 | HSINER CO., LTD. | HSINER JET NEBULIZER, MODEL HS-31100 | 12/21/2005 |
| K082009 | HSINER CO., LTD. | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS | 08/22/2008 |
| K994352 | HUDSON RESPIRATORY CARE, INC. | SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 | 03/22/2000 |
| K042546 | INFAMED LTD. | FUNHALER, MODEL FH 101 | 01/03/2005 |
| K072822 | INFAMED LTD. | FUNHALER, MODEL V-201E | 11/26/2007 |
| K991725 | INSPIRED MEDICAL PRODUCTS LTD. | SIDESTREAM NEBULIZER | 07/30/1999 |
| K991355 | INSTRUMENTATION INDUSTRIES, INC. | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | 01/27/2000 |
| K981249 | INSTRUMENTATION INDUSTRIES, INC. | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D | 11/23/1998 |
| K162753 | INSTRUMENTATION INDUSTRIES, INC. | RTC 26-C Inline Aerosol Adapter | 02/28/2017 |
| K091111 | INSTRUMENTATION INDUSTRIES, INC. | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC | 12/02/2009 |
| K101857 | INSTRUMENTATION INDUSTRIES, INC. | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | 07/22/2010 |
| K992643 | INVACARE CORP. | MODEL IRC 1001 AEROSOL COMPRESSOR | 10/27/1999 |
| K973468 | INVACARE CORP. | MODEL IRC 1199 SCOUT NEBULIZER | 12/08/1997 |
| K042483 | INVACARE CORPORATION | INVACARE PRO, COMPACT AND PORTABLE DESKTOP | 01/06/2005 |
| K243468 | JOYTECH Healthcare Co., Ltd. | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | 07/02/2025 |
| K051365 | K-JUMP HEALTH CO., LTD. | COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 | 07/22/2005 |
| K121520 | K-JUMP HEALTH CO., LTD. | ULTRASONIC NEBULIZER (MESH TYPE) | 03/15/2013 |
| K083256 | K-JUMP HEALTH CO., LTD. | ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 | 06/26/2009 |
| K112041 | KOO(SHANGHAI)INDUSTRIES CO., LTD. | KOO SMALL VOLUME NEBULIZER (SVN) | 12/22/2011 |
| K062811 | LIFE OUTCOMES, INC. | DPILOG, MODEL DPC-512 | 12/20/2006 |
| K990506 | MABIS HEALTHCARE, INC. | MABIS NB-02 ULTRASONIC NEBULIZER | 03/11/1999 |
| K232523 | Mankind Pharma Limited | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | 04/10/2024 |
| K041327 | MED2000 S.R.L. | MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES | 07/20/2004 |
| K031908 | MED2000 S.R.L. | MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) | 01/14/2004 |
| K072494 | MEDEL S.P.A. | AG-CLASSIC | 02/12/2008 |
| K063103 | MEDEL S.P.A. | AG-EDGE, MODEL 91200 | 01/08/2007 |
| K060404 | MEDEL S.P.A. | AG-PLUS, MODEL 91210 | 06/22/2006 |
| K082541 | MEDI NUCLEAR CORP., INC. | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM | 11/26/2008 |
| K080969 | MEDI NUCLEAR CORP., INC. | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 | 07/25/2008 |
| K080657 | MEDI NUCLEAR CORP., INC. | NEB-90 LARGE VOLUME MEDICATION NEBULIZER | 06/30/2008 |
| K981772 | MEDIC-AID LTD. | HALOLITE AAD SYSTEM | 11/03/1998 |
| K991685 | MEDIC-AID LTD. | HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR | 08/13/1999 |
| K971933 | MEDIC-AID LTD. | PORT-NEB | 08/01/1997 |
| K970844 | MEDICAL CONSULTING SERVICE, INC. | ATOMISOR | 11/13/1997 |
| K003344 | MEDICAL DEPOT, INC. | MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 | 03/15/2001 |
| K012006 | MEDICAL DEPOT, INC. | MEDICAL DEPOT POWER NEB 1 | 07/13/2001 |
| K964078 | MEDICAL INDUSTRIES AMERICA, INC. | 3050 SPORT-NEB | 01/10/1997 |
| K032170 | MEDICAL INDUSTRIES AMERICA, INC. | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | 05/28/2004 |
| K002153 | MEDISANA USA, INC. | ULTRASONIC NEBULIZER, MODEL NE-520 | 03/13/2001 |
| K220955 | Medline Industires, Inc. | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | 06/23/2023 |
| K230602 | Medline Industries LP | Hudson RCI« TurboMistÖ Nebulizer System | 10/31/2023 |
| K223100 | Medline Industries, Inc | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | 06/27/2023 |
| K231058 | Medline Industries, LP | Hudson RCI« AddiPak« Unit Dose Vial | 01/04/2024 |
| K970344 | MEDTRAK TECHNOLOGIES, INC. | MDILOG, MODEL MDC-511 | 08/06/1997 |
| K990185 | MEDTRAK TECHNOLOGIES, INC. | MDILOG, MODEL MDC-512 | 04/01/1999 |
| K053490 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER | 07/24/2006 |
| K092859 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS MODEL N SERIES NEBULIZER COMPRESSORS | 07/02/2010 |
| K180871 | MicroBase Technology Corporation | Portable Nebulizer | 09/14/2018 |
| K170916 | MicroBase Technology Corporation | Portable Nebulizer | 11/28/2017 |
| K142541 | MicroVaper Devices | POCKET NEB | 01/22/2016 |
| K012939 | MONAGHAN MEDICAL CORP. | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | 09/28/2001 |
| K110273 | MONAGHAN MEDICAL CORPORATION | AEROVENT PLUS CHC | 06/09/2011 |
| K220145 | Monaghan Medical Corporation | Monaghan medical filtered mouthpiece kit | 08/24/2023 |
| K971808 | MONARCH MEDICAL | SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES | 09/26/1997 |
| K020357 | NELLCOR PURITAN BENNETT, INC. | 800 SERIES EASYNEB NEBULIZER | 08/07/2002 |
| K113033 | NEPHRON PHARMACEUTICALS CORP. | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | 06/19/2012 |
| K120051 | NEPHRON PHARMACEUTICALS CORP. | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | 04/20/2012 |
| K041082 | NEWPORT MEDICAL INSTRUMENTS, INC. | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | 09/07/2004 |
| K133951 | NEXUS6, LTD. | SMARTTOUCH | 04/25/2014 |
| K091803 | NEXUS6, LTD. | SMARTTRACK SYSTEM | 10/09/2009 |
| K040439 | NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. | MDI TRIGGER GUARD | 07/08/2004 |
| K082878 | NSR COMERCIO E REPRESENTACOES LTDA | NEVONI CLASSIC, MODEL 6600-PO | 12/30/2008 |
| K223367 | Ochsner Clinic Foundation | Ochsner Connected Inhaler Sensor | 08/30/2023 |
| K112564 | ODYSSEY MEDICAL TECHNOLOGIES | QUIXIE NEBULIZER | 11/23/2011 |
| K141140 | OMRON HEALTHCARE, INC. | COMP A-I-R | 09/30/2014 |
| K110860 | OMRON HEALTHCARE, INC. | COMP A-I-R | 09/02/2011 |
| K060811 | OMRON HEALTHCARE, INC. | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 | 05/25/2006 |
| K062263 | OMRON HEALTHCARE, INC. | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 | 02/23/2007 |
| K960854 | PACESETTER, INC. | SIEMENS SERVO ULTRA NEBULIZER 345 | 12/23/1996 |
| K963924 | PARI HOLDING CO. | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 | 12/10/1996 |
| K962072 | PARI HOLDING CO. | PRONEB TURBO COMPRESSOR MODEL 38V0200 | 08/21/1996 |
| K960675 | PARI HOLDING CO. | WALKHALER PORTABLE COMPRESSOR MODEL 45F70 | 05/17/1996 |
| K033833 | PARI INNOVATIVE MANUFACTURERS, INC. | EFLOW ELECTRONIC INHALER/NEBULIZER | 05/05/2004 |
| K070498 | PARI INNOVATIVE MANUFACTURERS, INC. | HYPER SAL | 04/26/2007 |
| K060399 | PARI INNOVATIVE MANUFACTURERS, INC. | LC SPRINT NEBULIZER | 03/02/2006 |
| K062158 | PARI INNOVATIVE MANUFACTURERS, INC. | LC SPRINT STAR | 08/28/2006 |
| K061381 | PARI INNOVATIVE MANUFACTURERS, INC. | LC STAR WITH NASAL ADAPTER | 06/02/2006 |
| K072670 | PARI INNOVATIVE MANUFACTURERS, INC. | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER | 12/13/2007 |
| K060357 | PARI INNOVATIVE MANUFACTURERS, INC. | TREK S NEBULIZER COMPRESSOR | 04/05/2006 |
| K020944 | PARI INNOVATIVE MANUFACTURERS, INC. | VORTEX VALVED HOLDING CHAMBER | 05/09/2002 |
| K100380 | PARI RESPIRATORY EQUIPMENT, INC. | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | 02/22/2010 |
| K223840 | PARI Respiratory Equipment, Inc. | eRapid Nebulizer System | 08/11/2023 |
| K112859 | PARI RESPIRATORY EQUIPMENT, INC. | ERAPID NEBULIZER SYSTEM | 05/30/2012 |
| K092560 | PARI RESPIRATORY EQUIPMENT, INC. | PARI SINUS | 05/06/2010 |
| K092918 | PARI RESPIRATORY EQUIPMENT, INC. | PARI VIOS | 02/04/2010 |
| K191270 | PARI Respiratory Equipment, Inc. | Proneb Max | 01/23/2020 |
| K162785 | PARI Respiratory Equipment, Inc. | Velox Nebulizer System | 04/14/2017 |
| K122857 | PEGASUS RESEARCH CORP. | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | 11/07/2012 |
| K962534 | PEGASUS RESEARCH CORP. | THERA-MIST NEBULIZER MODEL-P3000 | 02/28/1997 |
| K101424 | PHARMACARIBE | PHARMACARIBE INHALED SALINE SOLUTIONS | 08/17/2010 |
| K130091 | PHARMACARIBE | PULMOSAL | 03/13/2013 |
| K982408 | PIPER MEDICAL PRODUCTS | AEROTEE, MODEL # 1001 | 09/14/1998 |
| K990384 | PIPER MEDICAL PRODUCTS | EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 | 04/26/1999 |
| K993558 | PIPER MEDICAL PRODUCTS | EZFLOW MAX, MODEL 1007 | 11/12/1999 |
| K042991 | PROFILE THERAPEUTICS PLC | I-NEB AAD SYSTEM | 09/23/2005 |
| K052941 | PROFILE THERAPEUTICS PLC | I-NEB INSIGHT AAD SYSTEM | 12/09/2005 |
| K030747 | PROFILE THERAPEUTICS PLC | PRODOSE AAD SYSTEM | 04/22/2004 |
| K980074 | PROJECT MARKETING | 56 SERIES AEROSOL GENERATOR | 06/12/1998 |
| K021443 | PROJECT MARKETING | 56 SERIES JET NEBULIZER | 10/21/2002 |
| K060497 | PROMEDIC, INC. | BABYAIR | 07/11/2006 |
| K060842 | PROMEDIC, INC. | REVJET TURBO | 06/21/2006 |
| K990897 | PURITAN-BENNETT IRELAND, LTD. | NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER | 03/15/2000 |
| K171549 | Qingdao Future Medical Technology Co., Ltd. | Intelligent Mesh Nebulizer | 08/31/2018 |
| K112824 | QUALITY LIFE TECHNOLOGIES CO;LTD | QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER | 06/21/2012 |
| K143671 | Reciprocal Labs | Propeller Model 2014-D Sensor | 06/19/2015 |
| K152482 | RECIPROCAL LABS | Propeller Sensor Model 2014-R | 03/04/2016 |
| K152882 | RECIPROCAL LABS | Propeller System | 03/08/2016 |
| K142960 | Reciprocal Labs | Propeller System 2014-R | 03/05/2015 |
| K121609 | RECIPROCAL LABS CORPORATION | ASTHMAPOLIS SYSTEM | 07/02/2012 |
| K180770 | Reciprocal Labs Corporation | Propeller Sensor for Neohaler | 08/01/2018 |
| K192724 | Reciprocal Labs Corporation | Propeller Sensor for Symbicort | 03/26/2020 |
| K161454 | Reciprocal Labs Corporation | Propeller Sensor Model 2015-E | 11/01/2016 |
| K142516 | RECIPROCAL LABS CORPORATION | Propeller System | 05/15/2015 |
| K140638 | RECIPROCAL LABS CORPORATION | PROPELLER SYSTEM - MODEL 2 | 05/02/2014 |
| K051284 | RESPIRICS, INC. | MD TURBO | 06/22/2005 |
| K032809 | RESPIRONICS HEALTHSCAN, INC. | HOSPITAL SPACER | 11/13/2003 |
| K062689 | RESPIRONICS LTD. | SIDESTREAM PLUS | 02/16/2007 |
| K042655 | RESPIRONICS NEW JERSEY, INC. | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 | 10/13/2004 |
| K100285 | RESPIRONICS NEW JERSEY, INC. | LITETOUCH MASK | 06/29/2010 |
| K053203 | RESPIRONICS NEW JERSEY, INC. | MYNEB NEBULIZER, MODEL RDD100 | 12/20/2005 |
| K072418 | RESPIRONICS NEW JERSEY, INC. | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER | 09/12/2007 |
| K102454 | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM | 10/25/2011 |
| K170853 | Respironics Respiratory Drug Delivery (UK) Ltd. | InnoSpire Go | 11/02/2017 |
| K130379 | ROLLINS MEDICAL SOLUTIONS, INC. | ROLLINS 7 OXYGEN MASK | 10/09/2013 |
| K992285 | SALTER LABS | SALTER AIRE COMPRESSOR | 01/07/2000 |
| K962085 | SALTER LABS | SALTER LABS 8990 SERIES NEBULIZER | 08/26/1996 |
| K014056 | SALTER LABS | SALTER LABS MODIFIED NEBUTECH NEBULIZER | 02/01/2002 |
| K983403 | SALTER LABS | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | 12/17/1998 |
| K991788 | SALTER LABS | SALTER LABS PEP DEVICE | 08/06/1999 |
| K992986 | SALTER LABS | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | 09/24/1999 |
| K962879 | SALTER LABS | SALTERLABS 8660 SERIES NEBULIZER | 10/22/1996 |
| K961476 | SALTER LABS | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | 07/16/1996 |
| K002543 | SAN UP S.A. | COMOACT ULTRASONIC NEBULIZER, MODEL 3060 | 06/14/2001 |
| K032516 | SENSORMEDICS CORP. | HIOX80 AEROSOL ADAPTER | 03/04/2004 |
| K170886 | Shenzhen Homed Medical Device Co,.Ltd. | HOMED Mesh Nebulizer | 06/21/2018 |
| K161586 | SHENZHEN HOMED MEDICAL DEVICE CO., LTD | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | 09/06/2017 |
| K212395 | Shenzhen Homed Medical Device Co., Ltd. | Nebulizer | 03/25/2022 |
| K201397 | Shenzhen Ivankaca Technology Co., Ltd | Ultrasonic Mesh Nebulizer | 06/14/2021 |
| K031370 | SHINING WORLD HEALTH CARE CO., LTD. | SHINMED MODE SW-988 UNTRASONIC NEBULIZER | 09/01/2004 |
| K980024 | SHINING WORLD HEALTH CARE CO., LTD. | SHINMED MODEL SW-966 ULTRASONIC NEBULIZER | 09/03/1999 |
| K050183 | SILVESTRIN FABRIS S.R.L. | SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES | 08/16/2005 |
| K101953 | SOUTHMEDIC, INC. | SMDIA-1000 | 01/07/2011 |
| K980829 | STERIPAK, LTD. | 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP | 06/02/1998 |
| K091794 | STEVE ISLAVA | CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 | 01/28/2010 |
| K020932 | SUNRISE MEDICAL | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR | 06/28/2002 |
| K993492 | SUNRISE MEDICAL HHG, INC. | DEVILBISS NEBULIZER MODEL 800 | 04/21/2000 |
| K140237 | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD | DISPOSABLE NEBULIZER SET | 01/08/2015 |
| K971981 | SYSTAM | LS SERIES 200 FLOVISION SYSTEM | 12/22/1998 |
| K122060 | TaiDoc Technology Corporation | CLEVER TD-7001NEBULIZER | 03/21/2013 |
| K121969 | TaiDoc Technology Corporation | U-RIGHT COMPRESSOR NEBULIZER | 02/28/2013 |
| K141214 | Teleflex Medical, Inc. | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS | 12/18/2014 |
| K142153 | Teleflex Medical, Inc. | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML | 04/29/2015 |
| K153010 | Teleflex Medical, Inc. | Hudson RCI AquaPak Sterile Prefilled Nebulizers | 07/26/2016 |
| K080230 | Teleflex Medical, Inc. | NEB-U-MASK SYSTEM, MODELS 1895, 1896 | 06/09/2008 |
| K972657 | TEXAS MEDICAL INDUSTRIES, INC. | ULTRAMIST 2000 | 02/02/1998 |
| K955805 | THAYER MEDICAL CORP. | DUAL SPRAY MINISPACER | 03/21/1996 |
| K972237 | THAYER MEDICAL CORP. | HAND HELD MEDISPACER | 07/31/1997 |
| K993101 | THAYER MEDICAL CORP. | LITEAIRE | 10/26/2000 |
| K102658 | THAYER MEDICAL CORP. | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS | 12/10/2010 |
| K992722 | THAYER MEDICAL CORP. | PRIMEAIRE | 11/10/1999 |
| K233553 | Thayer Medical Corporation | MiniSpacer« 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | 06/18/2024 |
| K111570 | THAYER MEDICAL CORPORATION | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR | 09/29/2011 |
| K210126 | The Ritedose Corporation | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | 12/03/2021 |
| K982179 | TRUDELL MEDICAL | TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER | 09/17/1998 |
| K982181 | TRUDELL MEDICAL | TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER | 01/08/1999 |
| K992917 | TRUDELL MEDICAL INT'L | AEROCHAMBER PLUS VALVED HOLDING CHAMBER | 09/14/1999 |
| K001137 | TRUDELL MEDICAL INT'L | AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) | 07/05/2000 |
| K140919 | TRUDELL MEDICAL INT'L | RESPICONNECT ADAPTER | 08/15/2014 |
| K200063 | Trudell Medical International | AeroEclipse* ONE BAN | 07/17/2020 |
| K203400 | Trudell Medical International | Corrugated tube with mouthpiece accessory | 06/14/2021 |
| K173367 | Trudell Medical International | MC 300* Nebulizer | 02/28/2018 |
| K173825 | Trudell Medical International | MC 300R* Nebulizer | 05/02/2018 |
| K032972 | TRUDELL MEDICAL INTL. | AEROCHAMBER MAX VALVED HOLDING CHAMBER | 01/14/2004 |
| K090065 | TRUDELL MEDICAL INTL. | AEROCHAMBER MINI VENTILATION CHAMBER | 04/09/2009 |
| K080926 | TRUDELL MEDICAL INTL. | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | 08/12/2008 |
| K053605 | TRUDELL MEDICAL INTL. | AEROECLIPSE II BREATH ACTUATED NEBULIZER | 02/27/2006 |
| K123614 | TRUDELL MEDICAL INTL. | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | 03/11/2013 |
| K962872 | TYCO HEALTHCARE DEUTSCHALAND GMBH | RESPIFLO | 02/25/1997 |
| K220869 | Vapotherm Inc. | Vapotherm Aerosol Adapter AAA-2 | 10/28/2022 |
| K142059 | VECTURA GMBH | FOX MOBILE | 01/09/2015 |
| K002831 | VEGA TECHNOLOGIES, INC. | VEGA ULTRASONIC NEBULIZER | 05/23/2001 |
| K981944 | VENTLAB CORP. | BREATHERITE | 08/24/1998 |
| K090840 | VENTLAB CORP. | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | 06/25/2009 |
| K962438 | VITAL SIGNS, INC. | MISTY OX TURBOHEATER | 01/13/1997 |
| K250022 | Voluntis | HeroTracker Sense | 06/30/2025 |
| K963910 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | HEART NEBULIZER #100609 | 12/16/1996 |
| K072136 | WILFRED KROMKER GMBH | ULTRASONIC NEBULISER MODEL 2010 | 07/15/2008 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
