Atlas FDA

CCQ

62 FDA 510(k) clearances · Product code

63 daysmedian time to decision
114 days90th percentile
62clearances measured

FDA profile

Official device name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device class
Class I (low risk)
Regulation
21 CFR 868.5640
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2013: 207 · 2014: 98 · 2015: 132 · 2016: 18 · 2017: 13 · 2025: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EZ SPRAY (K972397)Intertex Research, Inc.1997-09-23
E-Z SPACER MASK (SMALL) (K964956)Airpharma, LLC1997-04-23
MDI TUTOR (K961894)Mdi Tutor, Inc.1996-08-14
MEDSHIELD/AEROCHAMBER (K961455)Diemolding Corp.1996-07-25
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 (K960593)Aradigm Corp.1996-05-10
SALINE SOLUTION- STERILE (K922033)Trinity Laboratories, Inc.1992-07-21
MODIFIED AEROCHAMBER WITH MASK (K900576)Monaghan Medical Corp.1991-05-13
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (K900557)Monaghan Medical Corp.1991-04-10
FRANK INHALER THERMAL S (K895115)Buttner-Frank GmbH1990-05-18
EVOLUTION ULTRASONIC (K894215)Medical Industries America, Inc.1990-04-16
PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (K894555)Dura Pharmaceuticals, Inc.1990-01-24
PFEIFFER METERED DOSAGE SYSTEM (K896070)Syva Co.1990-01-17
FREEWAY NEBULIZER COMPRESSOR (K895592)Lifecare Services, Inc.1989-11-21
DEVILBISS MODEL 6610D (K894441)Devilbiss Health Care, Inc.1989-10-13
DEVILBISS MODEL 8500D AND 8500D-608 (K894244)Devilbiss Health Care, Inc.1989-10-06
GENTLEHALER(R) (K892117)Schering Research1989-06-23
DEY-PAK PURIFIED WATER, USP, STERILE (K875011)Dey Laboratories, Inc.1988-01-22
DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP (K875024)Dey Laboratories, Inc.1988-01-22
MONAGHAN AEROCHAMBER WITH MASK (K874513)Monaghan Medical Corp.1987-12-30
INSPIREASE(R), DRUG DELIVERY SYSTEM (K873793)Key Pharmaceuticals, Inc.1987-10-13
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) (K873477)Vortran Medical Technology 1, Inc.1987-10-09
MISTMASTER (K872315)Sonora Respiratory Products, Inc.1987-09-11
THE SPIRA ELEKTRO 2 (K871151)Warren E. Collins, Inc.1987-05-15
PREFILLED RESPIRATORY THERAPY VIALS (K870332)Automatic Liquid Packaging, Inc.1987-04-01
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER (K870027)Salter Labs1987-03-16
CHALLENGER DOSIMETER (K870755)Salter Labs1987-03-16
ROSENTHAL-FRENCH NEBULIZATION DOSIMETER (K860800)Laboratory For Applied Immunology, Inc.1986-03-27
CIRRUS DRUG NEBULIZER MK III (K860875)Dhd Medical Products Div. Diemolding Corp.1986-03-20
CIRRUS NEBULIZER-DELUXE KIT (K854952)Dhd Medical Products Div. Diemolding Corp.1986-01-28
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA (K854550)Medipart Jerry Alexander1985-12-19
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S (K854551)Medipart Jerry Alexander1985-12-19
PULMO-AIDE MODEL 5610D (K854520)The Devilbiss Co.1985-12-09
MAXI-NEB (K852627)Ashai Co. , Ltd.1985-09-26
MEDIX ELECTRONIC NEBULIZING SYSTEM (K853071)Medix Corp.1985-08-29
SYNCHRONER TM (PROPOSED TRADENAME) (K853350)Fisons Corp.1985-08-29
PFEIFFER PUMP (K851525)Ing. Erich Pfeiffer GmbH & Co. Kg.1985-08-08
MICRO-INHALER MODEL TV-7000 & TV-8000 (K851254)Bioclimatic, Inc.1985-06-18
MICRON ONE PORTA. ULTRASONIC NEBULIZER (K850926)Endotek Development Laboratories1985-05-23
MIST-EASE NEBULIZER (K844591)General Physiotherapy, Inc.1984-12-13
AVA-NEB NEBULIZER (K843102)Avatron, Inc.1984-08-17
VMT GENTLE-HALER (K842988)Vortran Medical Technology 1, Inc.1984-08-07
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT (K841989)Armour Pharmaceutical Co.1984-07-27
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS (K841991)Armour Pharmaceutical Co.1984-07-27
ARM-A-CARE NEBULIZER-NEBULIZER (K841990)Armour Pharmaceutical Co.1984-07-27
ARM-A-VIAL LV STERIAL WATER FOR INHALA (K841987)Armour Pharmaceutical Co.1984-07-27
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT (K841988)Armour Pharmaceutical Co.1984-07-27
CROUP TENT FRAME (K842192)Home Run Treadmill Co.1984-06-25
VMT HAND HELD NEBULIZER (K841894)Vortran Medical Technology 1, Inc.1984-06-05
MISTY OX DISPOS. NEBULIZER (K841469)Medical Molding Corp. of America1984-04-24
AIR-NEB NEBULIZER COMPRESSOR UNIT (K841321)Airmed Corp.1984-04-13
VIRALIZER NEBULIZER SPRAYER (K833474)Viral Response System, Inc.1983-12-27
INSPIREASE (K832037)Key Pharmaceuticals, Inc.1983-08-16
NEBULIZER CHRONOLOG & INTERPRETER (K823423)Advanced Technology Products, Inc.1982-12-15
SYNTEVENT ATOMIZER/NEBULIZER AEROSOL (K822625)Syva Co.1982-10-13
BOSCH HEARING INSTRUMENTS (K812503)Retlif, Inc.1981-09-24
TRAVELAIRE (K811404)B & F Medical Products, Inc.1981-06-09
NEBULIZERS (K810343)Todd Industries, Inc.1981-03-17
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC (K802281)Sherwood Medical Co.1980-10-03
MISER INHALATION DEVICE, PART NO. 700 (K800763)Vix Breathing Equipment Co.1980-04-24
DISPOSABLE INCENTIVE SPIROMETER (K781394)Inhal-O-Tech Medical Plastic1978-10-16
PULMO-SONIC (K781073)The Devilbiss Co.1978-09-27
DRUG NEBULIZER (K760580)Ohio Medical Products1976-09-21

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Every clearance here is in the API, with alerts when new ones post.