Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
FDA product code CCQ · Class I (low risk) · 21 CFR 868.5640 · Anesthesiology
62510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Armour Pharmaceutical Co. 5
- Monaghan Medical Corp. 3
- Vortran Medical Technology 1, Inc. 3
- Key Pharmaceuticals, Inc. 2
- Medipart Jerry Alexander 2
- Dhd Medical Products Div. Diemolding Corp. 2
- Salter Labs 2
- Dey Laboratories, Inc. 2
- Syva Co. 2
- Devilbiss Health Care, Inc. 2
- The Devilbiss Co. 2
- Advanced Technology Products, Inc. 1
- Ohio Medical Products 1
- Viral Response System, Inc. 1
- Airmed Corp. 1
- B & F Medical Products, Inc. 1
- Todd Industries, Inc. 1
- Sherwood Medical Co. 1
- Avatron, Inc. 1
- Intertex Research, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972397 | Ez SprayCCQ · Traditional | Intertex Research, Inc. | 09/23/1997SE |
| K964956 | E-Z Spacer Mask (Small)CCQ · Traditional | Airpharma, LLC | 04/23/1997SE |
| K961894 | Mdi TutorCCQ · Traditional | Mdi Tutor, Inc. | 08/14/1996SE |
| K961455 | Medshield/AerochamberCCQ · Traditional | Diemolding Corp. | 07/25/1996SE |
| K960593 | Smartmist Asthma Managment System, Smartmist, Model Number SM-100/SMARTMIST Spirometry…CCQ · Traditional | Aradigm Corp. | 05/10/1996SE |
| K922033 | Saline Solution- SterileCCQ · Traditional | Trinity Laboratories, Inc. | 07/21/1992SE |
| K900576 | Modified Aerochamber with MaskCCQ · Traditional | Monaghan Medical Corp. | 05/13/1991SE |
| K900557 | Modified Aerochamber M.V. Aerosol Holding ChamberCCQ · Traditional | Monaghan Medical Corp. | 04/10/1991SE |
| K895115 | Frank Inhaler Thermal SCCQ · Traditional | Buttner-Frank GmbH | 05/18/1990SE |
| K894215 | Evolution UltrasonicCCQ · Traditional | Medical Industries America, Inc. | 04/16/1990SE |
| K894555 | Pari Inhalierboy Type 37.80 Double InsulatedCCQ · Traditional | Dura Pharmaceuticals, Inc. | 01/24/1990SE |
| K896070 | Pfeiffer Metered Dosage SystemCCQ · Traditional | Syva Co. | 01/17/1990SE |
| K895592 | Freeway Nebulizer CompressorCCQ · Traditional | Lifecare Services, Inc. | 11/21/1989SE |
| K894441 | Devilbiss Model 6610DCCQ · Traditional | Devilbiss Health Care, Inc. | 10/13/1989SE |
| K894244 | Devilbiss Model 8500D and 8500D-608CCQ · Traditional | Devilbiss Health Care, Inc. | 10/06/1989SE |
| K892117 | Gentlehaler(R)CCQ · Traditional | Schering Research | 06/23/1989SE |
| K875024 | Dey-Pak and Dey-Vial Sodium Chloride Solution, UspCCQ · Traditional | Dey Laboratories, Inc. | 01/22/1988SE |
| K875011 | Dey-Pak Purified Water, Usp, SterileCCQ · Traditional | Dey Laboratories, Inc. | 01/22/1988SE |
| K874513 | Monaghan Aerochamber with MaskCCQ · Traditional | Monaghan Medical Corp. | 12/30/1987SE |
| K873793 | Inspirease(R), Drug Delivery SystemCCQ · Traditional | Key Pharmaceuticals, Inc. | 10/13/1987SE |
| K873477 | Intermittent Signal Actuated Nebulizer (Visan)CCQ · Traditional | Vortran Medical Technology 1, Inc. | 10/09/1987SE |
| K872315 | MistmasterCCQ · Traditional | Sonora Respiratory Products, Inc. | 09/11/1987SE |
| K871151 | The Spira Elektro 2CCQ · Traditional | Warren E. Collins, Inc. | 05/15/1987SE |
| K870332 | Prefilled Respiratory Therapy VialsCCQ · Traditional | Automatic Liquid Packaging, Inc. | 04/01/1987SE |
| K870755 | Challenger DosimeterCCQ · Traditional | Salter Labs | 03/16/1987SE |
| K870027 | Hand Held Pheumatic Powered (Disposable) NebulizerCCQ · Traditional | Salter Labs | 03/16/1987SE |
| K860800 | Rosenthal-French Nebulization DosimeterCCQ · Traditional | Laboratory For Applied Immunology, Inc. | 03/27/1986SE |
| K860875 | Cirrus Drug Nebulizer MK IIICCQ · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/20/1986SE |
| K854952 | Cirrus Nebulizer-Deluxe KitCCQ · Traditional | Dhd Medical Products Div. Diemolding Corp. | 01/28/1986SE |
| K854551 | Medipart Radioaerosol Delivery Sys for Ultravent SCCQ · Traditional | Medipart Jerry Alexander | 12/19/1985SE |
| K854550 | Medipart Remote Injection Sys for Ultravent RadioaCCQ · Traditional | Medipart Jerry Alexander | 12/19/1985SE |
| K854520 | Pulmo-Aide Model 5610DCCQ · Traditional | The Devilbiss Co. | 12/09/1985SE |
| K852627 | Maxi-NebCCQ · Traditional | Ashai Co. , Ltd. | 09/26/1985SE |
| K853350 | Synchroner TM (Proposed Tradename)CCQ · Traditional | Fisons Corp. | 08/29/1985SE |
| K853071 | Medix Electronic Nebulizing SystemCCQ · Traditional | Medix Corp. | 08/29/1985SE |
| K851525 | Pfeiffer PumpCCQ · Traditional | Ing. Erich Pfeiffer GmbH & Co. Kg. | 08/08/1985SE |
| K851254 | Micro-Inhaler Model TV-7000 & TV-8000CCQ · Traditional | Bioclimatic, Inc. | 06/18/1985SE |
| K850926 | Micron One Porta. Ultrasonic NebulizerCCQ · Traditional | Endotek Development Laboratories | 05/23/1985SE |
| K844591 | Mist-Ease NebulizerCCQ · Traditional | General Physiotherapy, Inc. | 12/13/1984SE |
| K843102 | Ava-Neb NebulizerCCQ · Traditional | Avatron, Inc. | 08/17/1984SE |
| K842988 | VMT Gentle-HalerCCQ · Traditional | Vortran Medical Technology 1, Inc. | 08/07/1984SE |
| K841991 | Arm-A-Care Humidifier-Respiratory GasCCQ · Traditional | Armour Pharmaceutical Co. | 07/27/1984SE |
| K841990 | Arm-A-Care Nebulizer-NebulizerCCQ · Traditional | Armour Pharmaceutical Co. | 07/27/1984SE |
| K841989 | Arm-A-Vial LV Sodium Chloride InhalatCCQ · Traditional | Armour Pharmaceutical Co. | 07/27/1984SE |
| K841988 | Arm-A-Vial LV Sodium, Chloride InhalatCCQ · Traditional | Armour Pharmaceutical Co. | 07/27/1984SE |
| K841987 | Arm-A-Vial LV Sterial Water for InhalaCCQ · Traditional | Armour Pharmaceutical Co. | 07/27/1984SE |
| K842192 | Croup Tent FrameCCQ · Traditional | Home Run Treadmill Co. | 06/25/1984SE |
| K841894 | VMT Hand Held NebulizerCCQ · Traditional | Vortran Medical Technology 1, Inc. | 06/05/1984SE |
| K841469 | Misty Ox Dispos. NebulizerCCQ · Traditional | Medical Molding Corp. of America | 04/24/1984SE |
| K841321 | Air-Neb Nebulizer Compressor UnitCCQ · Traditional | Airmed Corp. | 04/13/1984SE |
| K833474 | Viralizer Nebulizer SprayerCCQ · Traditional | Viral Response System, Inc. | 12/27/1983SE |
| K832037 | InspireaseCCQ · Traditional | Key Pharmaceuticals, Inc. | 08/16/1983SE |
| K823423 | Nebulizer Chronolog & InterpreterCCQ · Traditional | Advanced Technology Products, Inc. | 12/15/1982SE |
| K822625 | Syntevent Atomizer/Nebulizer AerosolCCQ · Traditional | Syva Co. | 10/13/1982SE |
| K812503 | Bosch Hearing InstrumentsCCQ · Traditional | Retlif, Inc. | 09/24/1981SE |
| K811404 | TravelaireCCQ · Traditional | B & F Medical Products, Inc. | 06/09/1981SE |
| K810343 | NebulizersCCQ · Traditional | Todd Industries, Inc. | 03/17/1981SE |
| K802281 | Sherwood Nano-Mist Nebulizer W/MouthpiecCCQ · Traditional | Sherwood Medical Co. | 10/03/1980SE |
| K800763 | Miser Inhalation Device, Part No. 700CCQ · Traditional | Vix Breathing Equipment Co. | 04/24/1980SE |
| K781394 | Disposable Incentive SpirometerCCQ · Traditional | Inhal-O-Tech Medical Plastic | 10/16/1978SE |
| K781073 | Pulmo-SonicCCQ · Traditional | The Devilbiss Co. | 09/27/1978SE |
| K760580 | Drug NebulizerCCQ · Traditional | Ohio Medical Products | 09/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0898-2017 Class II | Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | Teleflex Medical | 10/27/2016Terminated |
| Z-0386-2017 Class II | LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | Teleflex Medical | 10/27/2016Terminated |
| Z-0383-2017 Class II | FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | Teleflex Medical | 10/27/2016Terminated |
| Z-0382-2017 Class II | FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | Teleflex Medical | 10/27/2016Terminated |
| Z-0381-2017 Class II | LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | Teleflex Medical | 10/27/2016Terminated |
| Z-1373-2013 Class I | EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. | Nephron Pharmaceuticals Corp. | 04/30/2013Terminated |
| Z-1372-2013 Class I | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe…Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. | Nephron Pharmaceuticals Corp. | 04/30/2013Terminated |
| Z-1371-2013 Class I | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for…Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. | Nephron Pharmaceuticals Corp. | 04/30/2013Terminated |
| Z-0108-2012 | Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter…A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable… | Salter Laboratories, Division of Regulatory… | 03/25/2011Terminated |