Nebulizer (Direct Patient Interface)
FDA product code CAF · Class II (moderate risk) · 21 CFR 868.5630 · Anesthesiology
508510(k) clearances
0PMA approvals
34recalls
Manufacturers
- Airlife, Inc. 16
- Vortran Medical Technology 1, Inc. 12
- Adherium (Nz), Ltd. 10
- Reciprocal Labs Corporation 10
- Aerogen, Ltd. 9
- Thayer Medical Corp. 9
- Salter Labs 9
- Pari Innovative Manufacturers, Inc. 8
- Pari Respiratory Equipment, Inc. 8
- Travenol Laboratories, S.A. 8
- Omron Healthcare, Inc. 7
- Automatic Liquid Packaging, Inc. 7
- Medic-Aid , Ltd. 7
- B&B Medical Technologies, Inc. 6
- Devilbiss Health Care, Inc. 6
- Medical Industries America, Inc. 6
- Instrumentation Industries, Inc. 6
- Trudell Medical Intl. 5
- Monaghan Medical Corp. 5
- Pari Holding Co. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)CAF · Traditional | FindAir Sp. z o.o. | 06/02/2026SE |
| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%CAF · Traditional | Mankind Pharma Limited | 04/10/2024SE |
| K231058 | Hudson RCI® AddiPak® Unit Dose VialCAF · Traditional | Medline Industries, LP | 01/04/2024SE |
| K230379 | Portable (Ultrasonic) NebulizerCAF · Traditional | Dongguan Simzo Electronic Technology Co., Ltd. | 11/27/2023SE |
| K230602 | Hudson RCI® TurboMist Nebulizer SystemCAF · Traditional | Medline Industries, LP | 10/31/2023SE |
| K223367 | Ochsner Connected Inhaler SensorCAF · Traditional | Ochsner Clinic Foundation | 08/30/2023SE |
| K220145 | Monaghan medical filtered mouthpiece kitCAF · Traditional | Monaghan Medical Corporation | 08/24/2023SE |
| K223840 | eRapid Nebulizer SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 08/11/2023SE |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)CAF · Traditional | Medline Industries, Inc. | 06/27/2023SE |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770)CAF · Traditional | Medline Industires, Inc. | 06/23/2023SE |
| K222247 | Hailie Sensor NF0110CAF · Traditional | Adherium (Nz), Ltd. | 02/08/2023SE |
| K220869 | Vapotherm Aerosol Adapter AAA-2CAF · Traditional | Vapotherm, Inc. | 10/28/2022SE |
| K221994 | Hailie Sensor NF0107 & NF0108CAF · Traditional | Adherium (Nz), Ltd. | 10/04/2022SE |
| K220622 | Hailie Sensor NF0106CAF · Traditional | Adherium (Nz), Ltd. | 07/15/2022SE |
| K212395 | NebulizerCAF · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 03/25/2022SE |
| K211560 | Airvo Nebulizer AdapterCAF · Traditional | Fisher & Paykel Healthcare Limited | 12/10/2021SE |
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%CAF · Traditional | The Ritedose Corporation | 12/03/2021SE |
| K203155 | BreatheSuite MDI V1CAF · Traditional | Breathesuite, Inc. | 09/17/2021SE |
| K211233 | Hailie Sensor NF0109CAF · Traditional | Adherium (Nz), Ltd. | 08/18/2021SE |
| K192971 | Nebulizer KitCAF · Traditional | Excellentcare Medical (Huizhou) , Ltd. | 07/08/2021SE |
| K202171 | Pulmogine Vibrating Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 07/01/2021SE |
| K203400 | Corrugated tube with mouthpiece accessoryCAF · Traditional | Trudell Medical International | 06/14/2021SE |
| K201397 | Ultrasonic Mesh NebulizerCAF · Traditional | Shenzhen Ivankaca Technology Co., Ltd. | 06/14/2021SE |
| K201167 | AireHealth NebulizerTMCAF · Traditional | Airehealth, Inc. | 12/03/2020SE |
| K182906 | Portable Mesh NebulizerCAF · Traditional | Feellife Health, Inc. | 09/27/2020SE |
| K200063 | AeroEclipse* ONE BANCAF · Abbreviated | Trudell Medical International | 07/17/2020SE |
| K192633 | GUS831 Compressor NebulizerCAF · Traditional | Globalcare Medical Technology Co., Ltd. | 05/01/2020SE |
| K192724 | Propeller Sensor for SymbicortCAF · Traditional | Reciprocal Labs Corporation | 03/26/2020SE |
| K191270 | Proneb MaxCAF · Traditional | Pari Respiratory Equipment, Inc. | 01/23/2020SE |
| K183586 | CapMedicCAF · Traditional | Cognita Labs, LLC | 09/13/2019SE |
| K182638 | Hailie SensorCAF · Traditional | Adherium (Nz), Ltd. | 06/19/2019SE |
| K182573 | Hailie SensorCAF · Traditional | Adherium (Nz), Ltd. | 06/07/2019SE |
| K181405 | Hailie SensorCAF · Traditional | Adherium (Nz), Ltd. | 12/10/2018SE |
| K180871 | Portable NebulizerCAF · Traditional | Microbase Technology Corporation | 09/14/2018SE |
| K171549 | Intelligent Mesh NebulizerCAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 08/31/2018SE |
| K180770 | Propeller Sensor for NeohalerCAF · Traditional | Reciprocal Labs Corporation | 08/01/2018SE |
| K180407 | SmartinhalerCAF · Traditional | Adherium (Nz), Ltd. | 07/25/2018SE |
| K170886 | HOMED Mesh NebulizerCAF · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 06/21/2018SE |
| K173825 | MC 300R* NebulizerCAF · Traditional | Trudell Medical International | 05/02/2018SE |
| K173310 | SmartTouchCAF · Traditional | Adherium (Nz), Ltd. | 03/26/2018SE |
| K173367 | MC 300* NebulizerCAF · Traditional | Trudell Medical International | 02/28/2018SE |
| K170916 | Portable NebulizerCAF · Traditional | Microbase Technology Corporation | 11/28/2017SE |
| K170853 | InnoSpire GoCAF · Traditional | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 11/02/2017SE |
| K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS…CAF · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 09/06/2017SE |
| K163485 | SmartTouchCAF · Traditional | Adherium (Nz), Ltd. | 08/30/2017SE |
| K153748 | AirLife Misty Finity NebulizerCAF · Traditional | Care Fusion | 05/17/2017SE |
| K162041 | Airworks Nebulizer pe1200mCAF · Traditional | Convexity Scientific, LLC | 05/02/2017SE |
| K162785 | Velox Nebulizer SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 04/14/2017SE |
| K162753 | RTC 26-C Inline Aerosol AdapterCAF · Traditional | Instrumentation Industries, Inc. | 02/28/2017SE |
| K161454 | Propeller Sensor Model 2015-ECAF · Traditional | Reciprocal Labs Corporation | 11/01/2016SE |
| K153010 | Hudson RCI AquaPak Sterile Prefilled NebulizersCAF · Traditional | Teleflexmedical, Inc. | 07/26/2016SE |
| K152882 | Propeller SystemCAF · Traditional | Reciprocal Labs | 03/08/2016SE |
| K152482 | Propeller Sensor Model 2014-RCAF · Traditional | Reciprocal Labs | 03/04/2016SE |
| K142541 | Pocket NebCAF · Abbreviated | Microvaper Devices | 01/22/2016SE |
| K143719 | Aeroneb USB Contoller SystemCAF · Traditional | Aerogen Limited | 07/10/2015SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | Besmed Health Business Corp | 06/30/2015SE |
| K143671 | Propeller Model 2014-D SensorCAF · Traditional | Reciprocal Labs | 06/19/2015SE |
| K142516 | Propeller SystemCAF · Traditional | Reciprocal Labs Corporation | 05/15/2015SE |
| K142153 | Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLCAF · Traditional | Teleflexmedical, Inc. | 04/29/2015SE |
| K142960 | Propeller System 2014-RCAF · Traditional | Reciprocal Labs | 03/05/2015SE |
| K142059 | Fox MobileCAF · Traditional | Vectura GmbH | 01/09/2015SE |
| K140237 | Disposable Nebulizer SetCAF · Traditional | Suzhou Weikang Medical Apparatus Co., Ltd. | 01/08/2015SE |
| K141214 | Aquapak Nebulizer Adaptors/ReservoirsCAF · Traditional | Teleflexmedical, Inc. | 12/18/2014SE |
| K133360 | Aeroneb Solo; Aeroneb Solo AdapterCAF · Traditional | Aerogen, Ltd. | 10/17/2014SE |
| K141140 | Comp A-I-RCAF · Traditional | Omron Healthcare, Inc. | 09/30/2014SE |
| K140919 | Respiconnect AdapterCAF · Traditional | Trudell Medical Int'L | 08/15/2014SE |
| K133105 | Breeze Nebulizer (NBR-10X)CAF · Traditional | Digio2 International Co., Ltd. | 06/24/2014SE |
| K140211 | Ultrasonic Mesh NebulizerCAF · Special | Foshan Gaunying Electronics Co., Ltd. | 05/30/2014SE |
| K140638 | Propeller System - Model 2CAF · Traditional | Reciprocal Labs Corporation | 05/02/2014SE |
| K133951 | SmarttouchCAF · Traditional | Nexus6, Ltd. | 04/25/2014SE |
| K132247 | Ultrasonic Mesh NebulizerCAF · Traditional | Foshan Gaunying Electronics Co., Ltd. | 01/08/2014SE |
| K123030 | Compressor Nebulizer Model MCN-S600XXCAF · Traditional | Dongguan Aidisy Machinery & Electronic Equipment C | 12/19/2013SE |
| K130379 | Rollins 7 Oxygen MaskCAF · Traditional | Rollins Medical Solutions, Inc. | 10/09/2013SE |
| K123527 | AirlifeCAF · Traditional | Care Fusion | 04/25/2013SE |
| K121770 | Headstar Medical Small Volume Jet NebulizerCAF · Traditional | Headstar Medical Products Co., Ltd. | 04/17/2013SE |
| K122060 | Clever TD-7001NEBULIZERCAF · Traditional | Taidoc Technology Corporation | 03/21/2013SE |
| K121520 | Ultrasonic Nebulizer (Mesh Type)CAF · Abbreviated | K-Jump Health Co., Ltd. | 03/15/2013SE |
| K130091 | PulmosalCAF · Special | Pharmacaribe | 03/13/2013SE |
| K123614 | Solarys Ventilator Aerosol Delivery System (AS)CAF · Traditional | Trudell Medical Intl. | 03/11/2013SE |
| K121969 | U-Right Compressor NebulizerCAF · Traditional | Taidoc Technology Corporation | 02/28/2013SE |
| K122857 | Hope Continuous Nebulizer Model HOPE-11310, Heart Nebulizer Model HEART-100609…CAF · Traditional | Pegasus Research Corp. | 11/07/2012SE |
| K121154 | Ultrasonic NebulizerCAF · Traditional | Foshan Gaunying Electronics Co., Ltd. | 08/20/2012SE |
| K111246 | Spirale Drug Delivery SystemCAF · Traditional | Armstrong Medical , Ltd. | 08/10/2012SE |
| K121609 | Asthmapolis SystemCAF · Traditional | Reciprocal Labs Corporation | 07/02/2012SE |
| K112824 | Quality Life Technologies Compressor NebulizerCAF · Traditional | Quality Life Technologies Co;Ltd | 06/21/2012SE |
| K113033 | Sodium Chlorde Inhalation Solution, 0.9% USP-3MLCAF · Traditional | Nephron Pharmaceuticals Corp. | 06/19/2012SE |
| K112859 | Erapid Nebulizer SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 05/30/2012SE |
| K120939 | Aeroneb ProCAF · Special | Aerogen, Ltd. | 04/26/2012SE |
| K120051 | Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, USP-4MLCAF · Traditional | Nephron Pharmaceuticals Corp. | 04/20/2012SE |
| K112041 | Koo Small Volume Nebulizer (SVN)CAF · Traditional | Koo (Shanghai) Industries Co., Ltd. | 12/22/2011SE |
| K112564 | Quixie NebulizerCAF · Traditional | Odyssey Medical Technologies | 11/23/2011SE |
| K102454 | I-Neb Aad System with Tim; I-Neb Insight Aad SystemCAF · Traditional | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 10/25/2011SE |
| K111570 | Minispacer(R) Mdi Adapter with Counter Incrementing ActuatorCAF · Traditional | Thayer Medical Corporation | 09/29/2011SE |
| K110860 | Comp A-I-RCAF · Traditional | Omron Healthcare, Inc. | 09/02/2011SE |
| K102719 | Atlantean Trigger NebulizerCAF · Traditional | Atlantean Corporation | 07/01/2011SE |
| K110273 | Aerovent Plus CHCCAF · Traditional | Monaghan Medical Corporation | 06/09/2011SE |
| K103635 | Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085…CAF · Special | Aerogen, Ltd. | 05/13/2011SE |
| K101552 | Foshan Care Medical Nebulizer Model KYWH2001CAF · Traditional | Foshan Care Medical Technology Co., Ltd. | 03/14/2011SE |
| K101953 | SMDIA-1000CAF · Traditional | Southmedic, Inc. | 01/07/2011SE |
| K102658 | Minispacer Dual-Spray Mdi Adapter with 22MM (or 15MM) Od / 22MM Od/Id Connections / 15MM…CAF · Special | Thayer Medical Corp. | 12/10/2010SE |
| K102240 | Nivo Nebulizer SystemCAF · Special | Aerogen Ireland, Ltd. | 11/10/2010SE |
| K101424 | Pharmacaribe Inhaled Saline SolutionsCAF · Traditional | Pharmacaribe | 08/17/2010SE |
| K101857 | RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VCAF · Special | Instrumentation Industries, Inc. | 07/22/2010SE |
| K092859 | Merits Model N Series Nebulizer CompressorsCAF · Abbreviated | Merits Health Products Co., Ltd. | 07/02/2010SE |
| K100285 | Litetouch MaskCAF · Traditional | Respironics New Jersey, Inc. | 06/29/2010SE |
| K092560 | Pari SinusCAF · Traditional | Pari Respiratory Equipment, Inc. | 05/06/2010SE |
| K100380 | Altera Nebulizer System, Model 678G1002CAF · Traditional | Pari Respiratory Equipment, Inc. | 02/22/2010SE |
| K092918 | Pari ViosCAF · Traditional | Pari Respiratory Equipment, Inc. | 02/04/2010SE |
| K091794 | CARE2 Medical Nebulizer, Model 101/102, 201/202CAF · Traditional | Steve Islava | 01/28/2010SE |
| K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…CAF · Traditional | Instrumentation Industries, Inc. | 12/02/2009SE |
| K090730 | Akita JetCAF · Traditional | Activaero America, Inc. | 11/13/2009SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | Besmed Health Business Corp | 11/10/2009SE |
| K091803 | Smarttrack SystemCAF · Traditional | Nexus6, Ltd. | 10/09/2009SE |
| K083256 | Ultrasonic Nebulizer System, Model KN-9210CAF · Abbreviated | K-Jump Health Co., Ltd. | 06/26/2009SE |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.CAF · Traditional | Ventlab Corp. | 06/25/2009SE |
| K090307 | Ddi Ultrasonic Nebulizer SystemCAF · Traditional | Diagnostic Devices, Inc. | 06/18/2009SE |
| K090065 | Aerochamber Mini Ventilation ChamberCAF · Traditional | Trudell Medical Intl. | 04/09/2009SE |
| K082878 | Nevoni Classic, Model 6600-POCAF · Abbreviated | Nsr Comercio E Representacoes Ltda | 12/30/2008SE |
| K082541 | Healthline Medicator / Redineb Aerosol Drug Delivery SystemCAF · Traditional | Medi Nuclear Corp., Inc. | 11/26/2008SE |
| K081650 | Aeroneb Go NebulizerCAF · Special | Aerogen (Ireland), Ltd. | 10/23/2008SE |
| K081738 | Ultrasonic Nebulizer System, Model HL100CAF · Traditional | Health & Life Co., Ltd. | 09/17/2008SE |
| K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsCAF · Special | Hsiner Co., Ltd. | 08/22/2008SE |
| K080926 | Aeroeclipse Durable Breath Actuated NebulizerCAF · Traditional | Trudell Medical Intl. | 08/12/2008SE |
| K080969 | Healthline Redi-Neb Medication Nebulizer, Model RN-510CAF · Traditional | Medi Nuclear Corp., Inc. | 07/25/2008SE |
| K072136 | Ultrasonic Nebuliser Model 2010CAF · Traditional | Wilfred Kromker GmbH | 07/15/2008SE |
| K080657 | NEB-90 Large Volume Medication NebulizerCAF · Traditional | Medi Nuclear Corp., Inc. | 06/30/2008SE |
| K080230 | Neb-U-Mask System, Models 1895, 1896CAF · Traditional | Teleflexmedical, Inc. | 06/09/2008SE |
| K072163 | Happyneb II, Happyneb III, Speedy, Nebby Plus and Myneb, Model 5CAF · Traditional | 3A Health Care S.R.L. | 03/06/2008SE |
| K072494 | Ag-ClassicCAF · Abbreviated | Medel S.P.A. | 02/12/2008SE |
| K063716 | Aerosol SystemCAF · Traditional | Amici, Inc. | 12/28/2007SE |
| K072670 | Modification to: Eflow Electronic Inhaler/NebulizerCAF · Special | Pari Innovative Manufacturers, Inc. | 12/13/2007SE |
| K072822 | Funhaler, Model V-201ECAF · Traditional | Infamed , Ltd. | 11/26/2007SE |
| K072019 | AKITA2 ApixnebCAF · Traditional | Activaero America, Inc. | 11/05/2007SE |
| K070411 | Amsure NebulizerCAF · Traditional | Amsino International, Inc. | 10/01/2007SE |
| K072418 | Optichamber Advantage Anti-Static Valved Holding ChamberCAF · Traditional | Respironics New Jersey, Inc. | 09/12/2007SE |
| K072119 | Airlife Nebulizer CapCAF · Traditional | Cardinalhealth | 08/10/2007SE |
| K062484 | Flaem Nuova RF6 Basic and RF6 Plus NebulizersCAF · Traditional | Flaem Nuova S.P.A. | 06/08/2007SE |
| K070990 | Apex Medical Mobineb, 9R-027 SeriesCAF · Special | Apex Medical Corp. | 05/18/2007SE |
| K070642 | Aeroneb Professional Nebulizer SystemCAF · Special | Aerogen (Ireland), Ltd. | 05/07/2007SE |
| K070498 | Hyper SalCAF · Traditional | Pari Innovative Manufacturers, Inc. | 04/26/2007SE |
| K070948 | Hsiner Nebulizer BottleCAF · Special | Hsiner | 04/25/2007SE |
| K062014 | Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.NEB, Q03, FJ03, and Walkie-NebCAF · Traditional | Flaem Nuova S.P.A. | 03/22/2007SE |
| K063449 | Deluxe NebulizerCAF · Traditional | Access Point Medical, LLC | 03/01/2007SE |
| K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22CAF · Traditional | Omron Healthcare, Inc. | 02/23/2007SE |
| K062952 | C300 Series Air Nebulizer CompressorCAF · Traditional | Choice Smart Health Care Co. , Ltd. | 02/21/2007SE |
| K062689 | Sidestream PlusCAF · Traditional | Respironics , Ltd. | 02/16/2007SE |
| K063103 | Ag-Edge, Model 91200CAF · Abbreviated | Medel S.P.A. | 01/08/2007SE |
| K062811 | Dpilog, Model DPC-512CAF · Traditional | Life Outcomes, Inc. | 12/20/2006SE |
| K062158 | LC Sprint StarCAF · Traditional | Pari Innovative Manufacturers, Inc. | 08/28/2006SE |
| K053490 | Merits Health Products Portable NebulizerCAF · Abbreviated | Merits Health Products Co., Ltd. | 07/24/2006SE |
| K060497 | BabyairCAF · Traditional | Promedic, Inc. | 07/11/2006SE |
| K060404 | Ag-Plus, Model 91210CAF · Abbreviated | Medel S.P.A. | 06/22/2006SE |
| K060842 | Revjet TurboCAF · Traditional | Promedic, Inc. | 06/21/2006SE |
| K061381 | LC Star with Nasal AdapterCAF · Traditional | Pari Innovative Manufacturers, Inc. | 06/02/2006SE |
| K060811 | Omron Compressor Systems, Models NE-C28,NE-C30CAF · Traditional | Omron Healthcare, Inc. | 05/25/2006SE |
| K060357 | Trek S Nebulizer CompressorCAF · Traditional | Pari Innovative Manufacturers, Inc. | 04/05/2006SE |
| K053360 | Aerolife Ultrasonic Nebulizer, Model P2CCAF · Traditional | Aerovectrx Corporation | 03/23/2006SE |
| K060399 | LC Sprint NebulizerCAF · Traditional | Pari Innovative Manufacturers, Inc. | 03/02/2006SE |
| K053605 | Aeroeclipse II Breath Actuated NebulizerCAF · Special | Trudell Medical Intl. | 02/27/2006SE |
| K052438 | Emg Handle Nebulizer NB02 SeriesCAF · Abbreviated | Emg Technology Co., Ltd. | 01/31/2006SE |
| K052811 | Hsiner Jet Nebulizer, Model HS-31100CAF · Traditional | Hsiner Co., Ltd. | 12/21/2005SE |
| K053203 | Myneb Nebulizer, Model RDD100CAF · Traditional | Respironics New Jersey, Inc. | 12/20/2005SE |
| K052941 | I-Neb Insight Aad SystemCAF · Special | Profile Therapeutics Plc | 12/09/2005SE |
| K042991 | I-Neb Aad SystemCAF · Traditional | Profile Therapeutics Plc | 09/23/2005SE |
| K051260 | Schuco Mist and Schuco Deluxe MistCAF · Traditional | Allied Healthcare Products, Inc. | 09/15/2005SE |
| K050183 | Silfab Super 2 Max Compressor, N28 SeriesCAF · Traditional | Silvestrin Fabris S.R.L. | 08/16/2005SE |
| K051365 | Compressor Nebulizer System, Model KN-9321CAF · Abbreviated | K-Jump Health Co., Ltd. | 07/22/2005SE |
| K043238 | Compressor Nebulizer, Model Emg NBA02-XXX SeriesCAF · Abbreviated | Emg Technology Co., Ltd. | 07/06/2005SE |
| K051284 | MD TurboCAF · Traditional | Respirics, Inc. | 06/22/2005SE |
| K050104 | Apex Medical Minineb & MiniplusCAF · Special | Apex Medical Corp. | 02/16/2005SE |
| K042483 | Invacare Pro, Compact and Portable DesktopCAF · Traditional | Invacare Corporation | 01/06/2005SE |
| K042546 | Funhaler, Model FH 101CAF · Abbreviated | Infamed , Ltd. | 01/03/2005SE |
| K042655 | Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456CAF · Traditional | Respironics New Jersey, Inc. | 10/13/2004SE |
| K041079 | Guan Hong Ultrasonic Nebulizer, Model DR-103/AC-103CAF · Traditional | Guan Hong Enterprise Co., Ltd. | 09/28/2004SE |
| K041082 | Newport Nebsonic N550 Ultrasonic NebulizerCAF · Traditional | Newport Medical Instruments, Inc. | 09/07/2004SE |
| K031370 | Shinmed Mode SW-988 Untrasonic NebulizerCAF · Traditional | Shining World Health Care Co., Ltd. | 09/01/2004SE |
| K041327 | MED2000 SPA Nebulizer Andyflow, Model A1/C with AccessoriesCAF · Special | Med2000 S.R.L. | 07/20/2004SE |
| K040439 | Mdi Trigger GuardCAF · Traditional | North American Technical Services (Nats) Corp. | 07/08/2004SE |
| K041418 | Airlife Misty Finity Large Volume Continuous NebulizerCAF · Traditional | Cardinalhealth | 06/10/2004SE |
| K032170 | Transneb Compressor W/Nebulizer, Model 5000CAF · Traditional | Medical Industries America, Inc. | 05/28/2004SE |
| K030396 | Omni~Neb; Omni~MaxCAF · Traditional | B&B Medical Technologies, Inc. | 05/07/2004SE |
| K033833 | Eflow Electronic Inhaler/NebulizerCAF · Traditional | Pari Innovative Manufacturers, Inc. | 05/05/2004SE |
| K030747 | Prodose Aad SystemCAF · Abbreviated | Profile Therapeutics Plc | 04/22/2004SE |
| K040718 | TrustCAF · Traditional | Dhd Healthcare Corp. | 04/02/2004SE |
| K031982 | Birdsong Leverhaler, Model LH-1000CAF · Traditional | Birdsong Medical Devices, Inc. | 04/02/2004SE |
| K032516 | HIOX80 Aerosol AdapterCAF · Traditional | Sensor Medics Corp. | 03/04/2004SE |
| K032972 | Aerochamber Max Valved Holding ChamberCAF · Special | Trudell Medical Intl. | 01/14/2004SE |
| K031908 | MED2000 SPA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 SPA…CAF · Traditional | Med2000 S.R.L. | 01/14/2004SE |
| K032849 | Aeroneb Go Nebulizer, Model AG-AG2000CAF · Traditional | Aerogen, Inc. | 11/21/2003SE |
| K032809 | Hospital SpacerCAF · Traditional | Respironics Healthscan, Inc. | 11/13/2003SE |
| K030374 | Sonik Ldi 20 AirCAF · Traditional | Evit Labs, Inc. | 08/25/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2514-2023 Class I | HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP.…Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to… | MEDLINE INDUSTRIES, LP - Northfield | 08/04/2023Open, Classified |
| Z-1516-2021 Class II | ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of…The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1058-2019 Class II | Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor…The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential… | Sanrai International LLC | 08/29/2018Terminated |
| Z-0722-2019 Class I | Medline Prefilled 550 ml SterileLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0721-2019 Class I | Portex 5ml Normal Saline (0.9%) Unit DoseLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0720-2019 Class I | Portex Unit Dose 15 ml Normal SalineLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0719-2019 Class I | Portex Unit Dose 5 ml Normal Saline (0.9%)Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0718-2019 Class I | Medline Prefilled 350 ml SterileLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0717-2019 Class I | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0716-2019 Class I | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0715-2019 Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0714-2019 Class I | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0713-2019 Class I | Portex 500 ml Sterile Water USP Pour BottleLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0712-2019 Class I | Portex 1000 ml Sterile Water USP Pour BottleLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0711-2019 Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0710-2019 Class I | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-0384-2018 Class II | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical…SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the… | Valeant Pharmacueticals International | 03/13/2017Terminated |
| Z-1146-2017 Class II | Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm…The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with… | Thayer Medical Corporation | 09/29/2016Terminated |
| Z-0796-2016 Class II | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use…Reports that the T-piece does not fit on the nebulizer. | Salter Labs | 01/05/2016Terminated |
| Z-0795-2016 Class II | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative…Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) | Pharmacaribe llc | 12/29/2015Terminated |
| Z-2054-2016 Class II | Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only…Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | Nephron Pharmaceuticals Corp. | 11/16/2015Terminated |
| Z-2053-2016 Class II | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per…Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | Nephron Pharmaceuticals Corp. | 11/16/2015Terminated |
| Z-0674-2016 Class II | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2…The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect… | Valeant Pharmacueticals International | 09/21/2015Terminated |
| Z-0371-2016 Class II | Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol…SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control… | Valeant Pharmaceuticals North America LLC | 09/14/2015Terminated |
| Z-2781-2015 Class II | NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to…The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during… | Salter Labs | 08/04/2015Terminated |
| Z-1720-2015 Class II | Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy…Roscoe Medical has recently identified the need to update its user manual with additional warning statements… | Compass Health Brands | 04/20/2015Terminated |
| Z-0504-2015 Class II | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL…Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility… | Teleflex Medical | 09/03/2014Terminated |
| Z-0121-2015 Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple…Aerogen has received a small number of complaints in relation to the main power adapter manufactured by… | Aerogen Ltd. | 09/02/2014Terminated |
| Z-0120-2015 Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple…Aerogen has received a small number of complaints in relation to the main power adapter manufactured by… | Aerogen Ltd. | 09/02/2014Terminated |
| Z-0119-2015 Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple…Aerogen has received a small number of complaints in relation to the main power adapter manufactured by… | Aerogen Ltd. | 09/02/2014Terminated |
| Z-0118-2015 Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple…Aerogen has received a small number of complaints in relation to the main power adapter manufactured by… | Aerogen Ltd. | 09/02/2014Terminated |
| Z-1927-2012 Class II | AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler…Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI)… | Thayer Medical Corporation | 06/06/2012Terminated |
| Z-3016-2011 | AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of…The recall was initiated because CareFusion's Investigation has confirmed the Nebulizer Heater can, over… | Carefusion 211 Inc | 07/13/2011Terminated |
| Z-0211-2008 | HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770…Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this… | Teleflex Creek Dr | 08/22/2007Terminated |