CAF · Nebulizer (Direct Patient Interface)
Anesthesiology · 21 CFR 868.5630 · Class 2
Overview
| Product Code | CAF |
|---|---|
| Device Name | Nebulizer (Direct Patient Interface) |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Cleared Devices (507)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | Dec 19, 2025 | SESE |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | Nov 14, 2025 | SESE |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | Sep 19, 2025 | SESE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | Jul 2, 2025 | SESE |
| K250022 | HeroTracker Sense | Voluntis | Jun 30, 2025 | SESE |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | Jun 20, 2025 | SESE |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | Apr 29, 2025 | SESE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | Jun 18, 2024 | SESE |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | May 10, 2024 | SESE |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | Apr 10, 2024 | SESE |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | Jan 4, 2024 | SESE |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | Nov 27, 2023 | SESE |
| K230602 | Hudson RCI® TurboMist Nebulizer System | Medline Industries, LP | Oct 31, 2023 | SESE |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | Aug 30, 2023 | SESE |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | Aug 24, 2023 | SESE |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | Aug 11, 2023 | SESE |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Medline Industries, Inc. | Jun 27, 2023 | SESE |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. | Jun 23, 2023 | SESE |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | Feb 8, 2023 | SESE |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | Oct 28, 2022 | SESE |
| K221994 | Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. | Oct 4, 2022 | SESE |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | Jul 15, 2022 | SESE |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | Mar 25, 2022 | SESE |
| K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | Dec 10, 2021 | SESE |
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | Dec 3, 2021 | SESE |
| K203155 | BreatheSuite MDI V1 | Breathesuite, Inc. | Sep 17, 2021 | SESE |
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | Aug 18, 2021 | SESE |
| K192971 | Nebulizer Kit | Excellentcare Medical (Huizhou) , Ltd. | Jul 8, 2021 | SESE |
| K202171 | Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. | Jul 1, 2021 | SESE |
| K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | Jun 14, 2021 | SESE |
| K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | Jun 14, 2021 | SESE |
| K201167 | AireHealth NebulizerTM | Airehealth, Inc. | Dec 3, 2020 | SESE |
| K182906 | Portable Mesh Nebulizer | Feellife Health, Inc. | Sep 27, 2020 | SESE |
| K200063 | AeroEclipse* ONE BAN | Trudell Medical International | Jul 17, 2020 | SESE |
| K192633 | GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd. | May 1, 2020 | SESE |
| K192724 | Propeller Sensor for Symbicort | Reciprocal Labs Corporation | Mar 26, 2020 | SESE |
| K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | Jan 23, 2020 | SESE |
| K183586 | CapMedic | Cognita Labs, LLC | Sep 13, 2019 | SESE |
| K182638 | Hailie Sensor | Adherium (Nz), Ltd. | Jun 19, 2019 | SESE |
| K182573 | Hailie Sensor | Adherium (Nz), Ltd. | Jun 7, 2019 | SESE |
| K181405 | Hailie Sensor | Adherium (Nz), Ltd. | Dec 10, 2018 | SESE |
| K180871 | Portable Nebulizer | Microbase Technology Corporation | Sep 14, 2018 | SESE |
| K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | Aug 31, 2018 | SESE |
| K180770 | Propeller Sensor for Neohaler | Reciprocal Labs Corporation | Aug 1, 2018 | SESE |
| K180407 | Smartinhaler | Adherium (Nz), Ltd. | Jul 25, 2018 | SESE |
| K170886 | HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | Jun 21, 2018 | SESE |
| K173825 | MC 300R* Nebulizer | Trudell Medical International | May 2, 2018 | SESE |
| K173310 | SmartTouch | Adherium (Nz), Ltd. | Mar 26, 2018 | SESE |
| K173367 | MC 300* Nebulizer | Trudell Medical International | Feb 28, 2018 | SESE |
| K170916 | Portable Nebulizer | Microbase Technology Corporation | Nov 28, 2017 | SESE |
| K170853 | InnoSpire Go | Respironics Respiratory Drug Delivery (Uk) , Ltd. | Nov 2, 2017 | SESE |
| K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | Shenzhen Homed Medical Device Co., Ltd. | Sep 6, 2017 | SESE |
| K163485 | SmartTouch | Adherium (Nz), Ltd. | Aug 30, 2017 | SESE |
| K153748 | AirLife Misty Finity Nebulizer | Care Fusion | May 17, 2017 | SESE |
| K162041 | Airworks Nebulizer pe1200m | Convexity Scientific, LLC | May 2, 2017 | SESE |
| K162785 | Velox Nebulizer System | Pari Respiratory Equipment, Inc. | Apr 14, 2017 | SESE |
| K162753 | RTC 26-C Inline Aerosol Adapter | Instrumentation Industries, Inc. | Feb 28, 2017 | SESE |
| K161454 | Propeller Sensor Model 2015-E | Reciprocal Labs Corporation | Nov 1, 2016 | SESE |
| K153010 | Hudson RCI AquaPak Sterile Prefilled Nebulizers | Teleflexmedical, Inc. | Jul 26, 2016 | SESE |
| K152882 | Propeller System | Reciprocal Labs | Mar 8, 2016 | SESE |
| K152482 | Propeller Sensor Model 2014-R | Reciprocal Labs | Mar 4, 2016 | SESE |
| K142541 | POCKET NEB | Microvaper Devices | Jan 22, 2016 | SESE |
| K143719 | Aeroneb USB Contoller System | Aerogen Limited | Jul 10, 2015 | SESE |
| K150591 | Besmed Reusable Jet Nebulizer | Besmed Health Business Corp | Jun 30, 2015 | SESE |
| K143671 | Propeller Model 2014-D Sensor | Reciprocal Labs | Jun 19, 2015 | SESE |
| K142516 | Propeller System | Reciprocal Labs Corporation | May 15, 2015 | SESE |
| K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML | Teleflexmedical, Inc. | Apr 29, 2015 | SESE |
| K142960 | Propeller System 2014-R | Reciprocal Labs | Mar 5, 2015 | SESE |
| K142059 | FOX MOBILE | Vectura GmbH | Jan 9, 2015 | SESE |
| K140237 | DISPOSABLE NEBULIZER SET | Suzhou Weikang Medical Apparatus Co., Ltd. | Jan 8, 2015 | SESE |
| K141214 | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS | Teleflexmedical, Inc. | Dec 18, 2014 | SESE |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | Aerogen, Ltd. | Oct 17, 2014 | SESE |
| K141140 | COMP A-I-R | Omron Healthcare, Inc. | Sep 30, 2014 | SESE |
| K140919 | RESPICONNECT ADAPTER | Trudell Medical Int'L | Aug 15, 2014 | SESE |
| K133105 | BREEZE NEBULIZER (NBR-10X) | Digio2 International Co., Ltd. | Jun 24, 2014 | SESE |
| K140211 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | May 30, 2014 | SESE |
| K140638 | PROPELLER SYSTEM - MODEL 2 | Reciprocal Labs Corporation | May 2, 2014 | SESE |
| K133951 | SMARTTOUCH | Nexus6, Ltd. | Apr 25, 2014 | SESE |
| K132247 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | Jan 8, 2014 | SESE |
| K123030 | COMPRESSOR NEBULIZER MODEL MCN-S600XX | Dongguan Aidisy Machinery & Electronic Equipment C | Dec 19, 2013 | SESE |
| K130379 | ROLLINS 7 OXYGEN MASK | Rollins Medical Solutions, Inc. | Oct 9, 2013 | SESE |
| K123527 | AIRLIFE | Care Fusion | Apr 25, 2013 | SESE |
| K121770 | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER | Headstar Medical Products Co., Ltd. | Apr 17, 2013 | SESE |
| K122060 | CLEVER TD-7001NEBULIZER | Taidoc Technology Corporation | Mar 21, 2013 | SESE |
| K121520 | ULTRASONIC NEBULIZER (MESH TYPE) | K-Jump Health Co., Ltd. | Mar 15, 2013 | SESE |
| K130091 | PULMOSAL | Pharmacaribe | Mar 13, 2013 | SESE |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | Trudell Medical Intl. | Mar 11, 2013 | SESE |
| K121969 | U-RIGHT COMPRESSOR NEBULIZER | Taidoc Technology Corporation | Feb 28, 2013 | SESE |
| K122857 | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | Pegasus Research Corp. | Nov 7, 2012 | SESE |
| K121154 | ULTRASONIC NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | Aug 20, 2012 | SESE |
| K111246 | SPIRALE DRUG DELIVERY SYSTEM | Armstrong Medical , Ltd. | Aug 10, 2012 | SESE |
| K121609 | ASTHMAPOLIS SYSTEM | Reciprocal Labs Corporation | Jul 2, 2012 | SESE |
| K112824 | QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER | Quality Life Technologies Co;Ltd | Jun 21, 2012 | SESE |
| K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | Nephron Pharmaceuticals Corp. | Jun 19, 2012 | SESE |
| K112859 | ERAPID NEBULIZER SYSTEM | Pari Respiratory Equipment, Inc. | May 30, 2012 | SESE |
| K120939 | AERONEB PRO | Aerogen, Ltd. | Apr 26, 2012 | SESE |
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | Nephron Pharmaceuticals Corp. | Apr 20, 2012 | SESE |
| K112041 | KOO SMALL VOLUME NEBULIZER (SVN) | Koo (Shanghai) Industries Co., Ltd. | Dec 22, 2011 | SESE |
| K112564 | QUIXIE NEBULIZER | Odyssey Medical Technologies | Nov 23, 2011 | SESE |
| K102454 | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM | Respironics Respiratory Drug Delivery (Uk) , Ltd. | Oct 25, 2011 | SESE |
| K111570 | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR | Thayer Medical Corporation | Sep 29, 2011 | SESE |
| K110860 | COMP A-I-R | Omron Healthcare, Inc. | Sep 2, 2011 | SESE |
| K102719 | ATLANTEAN TRIGGER NEBULIZER | Atlantean Corporation | Jul 1, 2011 | SESE |
| K110273 | AEROVENT PLUS CHC | Monaghan Medical Corporation | Jun 9, 2011 | SESE |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | Aerogen, Ltd. | May 13, 2011 | SESE |
| K101552 | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 | Foshan Care Medical Technology Co., Ltd. | Mar 14, 2011 | SESE |
| K101953 | SMDIA-1000 | Southmedic, Inc. | Jan 7, 2011 | SESE |
| K102658 | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS | Thayer Medical Corp. | Dec 10, 2010 | SESE |
| K102240 | NIVO NEBULIZER SYSTEM | Aerogen Ireland, Ltd. | Nov 10, 2010 | SESE |
| K101424 | PHARMACARIBE INHALED SALINE SOLUTIONS | Pharmacaribe | Aug 17, 2010 | SESE |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | Instrumentation Industries, Inc. | Jul 22, 2010 | SESE |
| K092859 | MERITS MODEL N SERIES NEBULIZER COMPRESSORS | Merits Health Products Co., Ltd. | Jul 2, 2010 | SESE |
| K100285 | LITETOUCH MASK | Respironics New Jersey, Inc. | Jun 29, 2010 | SESE |
| K092560 | PARI SINUS | Pari Respiratory Equipment, Inc. | May 6, 2010 | SESE |
| K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | Pari Respiratory Equipment, Inc. | Feb 22, 2010 | SESE |
| K092918 | PARI VIOS | Pari Respiratory Equipment, Inc. | Feb 4, 2010 | SESE |
| K091794 | CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 | Steve Islava | Jan 28, 2010 | SESE |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC | Instrumentation Industries, Inc. | Dec 2, 2009 | SESE |
| K090730 | AKITA JET | Activaero America, Inc. | Nov 13, 2009 | SESE |
| K091272 | BESMED JET NEBULIZER BOTTLE SET | Besmed Health Business Corp | Nov 10, 2009 | SESE |
| K091803 | SMARTTRACK SYSTEM | Nexus6, Ltd. | Oct 9, 2009 | SESE |
| K083256 | ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 | K-Jump Health Co., Ltd. | Jun 26, 2009 | SESE |
| K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | Ventlab Corp. | Jun 25, 2009 | SESE |
| K090307 | DDI ULTRASONIC NEBULIZER SYSTEM | Diagnostic Devices, Inc. | Jun 18, 2009 | SESE |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | Trudell Medical Intl. | Apr 9, 2009 | SESE |
| K082878 | NEVONI CLASSIC, MODEL 6600-PO | Nsr Comercio E Representacoes Ltda | Dec 30, 2008 | SESE |
| K082541 | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM | Medi Nuclear Corp., Inc. | Nov 26, 2008 | SESE |
| K081650 | AERONEB GO NEBULIZER | Aerogen (Ireland), Ltd. | Oct 23, 2008 | SESE |
| K081738 | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 | Health & Life Co., Ltd. | Sep 17, 2008 | SESE |
| K082009 | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS | Hsiner Co., Ltd. | Aug 22, 2008 | SESE |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | Trudell Medical Intl. | Aug 12, 2008 | SESE |
| K080969 | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 | Medi Nuclear Corp., Inc. | Jul 25, 2008 | SESE |
| K072136 | ULTRASONIC NEBULISER MODEL 2010 | Wilfred Kromker GmbH | Jul 15, 2008 | SESE |
| K080657 | NEB-90 LARGE VOLUME MEDICATION NEBULIZER | Medi Nuclear Corp., Inc. | Jun 30, 2008 | SESE |
| K080230 | NEB-U-MASK SYSTEM, MODELS 1895, 1896 | Teleflexmedical, Inc. | Jun 9, 2008 | SESE |
| K072163 | HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 | 3A Health Care S.R.L. | Mar 6, 2008 | SESE |
| K072494 | AG-CLASSIC | Medel S.P.A. | Feb 12, 2008 | SESE |
| K063716 | AEROSOL SYSTEM | Amici, Inc. | Dec 28, 2007 | SESE |
| K072670 | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER | Pari Innovative Manufacturers, Inc. | Dec 13, 2007 | SESE |
| K072822 | FUNHALER, MODEL V-201E | Infamed , Ltd. | Nov 26, 2007 | SESE |
| K072019 | AKITA2 APIXNEB | Activaero America, Inc. | Nov 5, 2007 | SESE |
| K070411 | AMSURE NEBULIZER | Amsino International, Inc. | Oct 1, 2007 | SESE |
| K072418 | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | Sep 12, 2007 | SESE |
| K072119 | AIRLIFE NEBULIZER CAP | Cardinalhealth | Aug 10, 2007 | SESE |
| K062484 | FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS | Flaem Nuova S.P.A. | Jun 8, 2007 | SESE |
| K070990 | APEX MEDICAL MOBINEB, 9R-027 SERIES | Apex Medical Corp. | May 18, 2007 | SESE |
| K070642 | AERONEB PROFESSIONAL NEBULIZER SYSTEM | Aerogen (Ireland), Ltd. | May 7, 2007 | SESE |
| K070498 | HYPER SAL | Pari Innovative Manufacturers, Inc. | Apr 26, 2007 | SESE |
| K070948 | HSINER NEBULIZER BOTTLE | Hsiner | Apr 25, 2007 | SESE |
| K062014 | FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB | Flaem Nuova S.P.A. | Mar 22, 2007 | SESE |
| K063449 | DELUXE NEBULIZER | Access Point Medical, LLC | Mar 1, 2007 | SESE |
| K062263 | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 | Omron Healthcare, Inc. | Feb 23, 2007 | SESE |
| K062952 | C300 SERIES AIR NEBULIZER COMPRESSOR | Choice Smart Health Care Co. , Ltd. | Feb 21, 2007 | SESE |
| K062689 | SIDESTREAM PLUS | Respironics , Ltd. | Feb 16, 2007 | SESE |
| K063103 | AG-EDGE, MODEL 91200 | Medel S.P.A. | Jan 8, 2007 | SESE |
| K062811 | DPILOG, MODEL DPC-512 | Life Outcomes, Inc. | Dec 20, 2006 | SESE |
| K062158 | LC SPRINT STAR | Pari Innovative Manufacturers, Inc. | Aug 28, 2006 | SESE |
| K053490 | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER | Merits Health Products Co., Ltd. | Jul 24, 2006 | SESE |
| K060497 | BABYAIR | Promedic, Inc. | Jul 11, 2006 | SESE |
| K060404 | AG-PLUS, MODEL 91210 | Medel S.P.A. | Jun 22, 2006 | SESE |
| K060842 | REVJET TURBO | Promedic, Inc. | Jun 21, 2006 | SESE |
| K061381 | LC STAR WITH NASAL ADAPTER | Pari Innovative Manufacturers, Inc. | Jun 2, 2006 | SESE |
| K060811 | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 | Omron Healthcare, Inc. | May 25, 2006 | SESE |
| K060357 | TREK S NEBULIZER COMPRESSOR | Pari Innovative Manufacturers, Inc. | Apr 5, 2006 | SESE |
| K053360 | AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C | Aerovectrx Corporation | Mar 23, 2006 | SESE |
| K060399 | LC SPRINT NEBULIZER | Pari Innovative Manufacturers, Inc. | Mar 2, 2006 | SESE |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | Trudell Medical Intl. | Feb 27, 2006 | SESE |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | Emg Technology Co., Ltd. | Jan 31, 2006 | SESE |
| K052811 | HSINER JET NEBULIZER, MODEL HS-31100 | Hsiner Co., Ltd. | Dec 21, 2005 | SESE |
| K053203 | MYNEB NEBULIZER, MODEL RDD100 | Respironics New Jersey, Inc. | Dec 20, 2005 | SESE |
| K052941 | I-NEB INSIGHT AAD SYSTEM | Profile Therapeutics Plc | Dec 9, 2005 | SESE |
| K042991 | I-NEB AAD SYSTEM | Profile Therapeutics Plc | Sep 23, 2005 | SESE |
| K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST | Allied Healthcare Products, Inc. | Sep 15, 2005 | SESE |
| K050183 | SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES | Silvestrin Fabris S.R.L. | Aug 16, 2005 | SESE |
| K051365 | COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 | K-Jump Health Co., Ltd. | Jul 22, 2005 | SESE |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | Emg Technology Co., Ltd. | Jul 6, 2005 | SESE |
| K051284 | MD TURBO | Respirics, Inc. | Jun 22, 2005 | SESE |
| K050104 | APEX MEDICAL MININEB & MINIPLUS | Apex Medical Corp. | Feb 16, 2005 | SESE |
| K042483 | INVACARE PRO, COMPACT AND PORTABLE DESKTOP | Invacare Corporation | Jan 6, 2005 | SESE |
| K042546 | FUNHALER, MODEL FH 101 | Infamed , Ltd. | Jan 3, 2005 | SESE |
| K042655 | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 | Respironics New Jersey, Inc. | Oct 13, 2004 | SESE |
| K041079 | GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 | Guan Hong Enterprise Co., Ltd. | Sep 28, 2004 | SESE |
| K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | Newport Medical Instruments, Inc. | Sep 7, 2004 | SESE |
| K031370 | SHINMED MODE SW-988 UNTRASONIC NEBULIZER | Shining World Health Care Co., Ltd. | Sep 1, 2004 | SESE |
| K041327 | MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES | Med2000 S.R.L. | Jul 20, 2004 | SESE |
| K040439 | MDI TRIGGER GUARD | North American Technical Services (Nats) Corp. | Jul 8, 2004 | SESE |
| K041418 | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER | Cardinalhealth | Jun 10, 2004 | SESE |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | Medical Industries America, Inc. | May 28, 2004 | SESE |
| K030396 | OMNI~NEB; OMNI~MAX | B&B Medical Technologies, Inc. | May 7, 2004 | SESE |
| K033833 | EFLOW ELECTRONIC INHALER/NEBULIZER | Pari Innovative Manufacturers, Inc. | May 5, 2004 | SESE |
| K030747 | PRODOSE AAD SYSTEM | Profile Therapeutics Plc | Apr 22, 2004 | SESE |
| K040718 | TRUST | Dhd Healthcare Corp. | Apr 2, 2004 | SESE |
| K031982 | BIRDSONG LEVERHALER, MODEL LH-1000 | Birdsong Medical Devices, Inc. | Apr 2, 2004 | SESE |
| K032516 | HIOX80 AEROSOL ADAPTER | Sensor Medics Corp. | Mar 4, 2004 | SESE |
| K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER | Trudell Medical Intl. | Jan 14, 2004 | SESE |
| K031908 | MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) | Med2000 S.R.L. | Jan 14, 2004 | SESE |
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 | Aerogen, Inc. | Nov 21, 2003 | SESE |
| K032809 | HOSPITAL SPACER | Respironics Healthscan, Inc. | Nov 13, 2003 | SESE |
| K030374 | SONIK LDI 20 AIR | Evit Labs, Inc. | Aug 25, 2003 | SESE |
| K023602 | SMALL VOLUME NEBULIZER | Allegiance Healthcare Corporation | May 1, 2003 | SESE |
Top Applicants
- Airlife, Inc. — 16 clearances
- Vortran Medical Technology 1, Inc. — 12 clearances
- Adherium (Nz), Ltd. — 10 clearances
- Salter Labs — 9 clearances
- Travenol Laboratories, S.A. — 8 clearances
