Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- K130304LMA FAMILY OF AIRWAYS1Cleared 510(K)
- K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 3051Cleared 510(K)
- K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 2051Cleared 510(K)
- K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 1051Cleared 510(K)
- K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)1Cleared 510(K)
- K960240RUSCH OPTOSAFE1Cleared 510(K)
- K950613KEISEI1Cleared 510(K)
- K953400GUEDEL AIRWAY1Cleared 510(K)
- K933760STB GUEDEL AIRWAY1Cleared 510(K)
- K936134BERMAN AIRWAY1Cleared 510(K)
- K922748GUEDEL AIRWAY1Cleared 510(K)
- K913680BERMAN INTUBATING/PHARYNGEAL AIRWAY1Cleared 510(K)
- K904834INTAVENT LARYNGEAL MASK1Cleared 510(K)
- K891926KISS OF LIFE1Cleared 510(K)
- K892123GOETTINGER EMERGENCY RESUSCITATION TUBE1Cleared 510(K)
- K891586ORAL AIRWAY1Cleared 510(K)
- K892053RESPAKIT1Cleared 510(K)
- K890566BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES1Cleared 510(K)
- K883593#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY1Cleared 510(K)
- K881065RESUS-AID1Cleared 510(K)
- K880241'HILT-WAY' RESUSCITATOR1Cleared 510(K)
- K874412THE PROTECTOR1Cleared 510(K)
- K871403MODIFIED C.P.R. MICROSHIELD1Cleared 510(K)
- K861482RESUSIKIT1Cleared 510(K)
- K862199MEDTECH C.P.R. MASK1Cleared 510(K)
- K860949DUAL-AID1Cleared 510(K)
- K861540DISPOSABLE BERMAN AND GUEDEL AIRWAYS1Cleared 510(K)
- K861054DISPOSABLE RESCUE BREATHING DEVICE1Cleared 510(K)
- K860780PLASTIC MOUTH BARRIER HCV-E1Cleared 510(K)
- K855137CURITY FIBEROPTIC INTUBATING AIRWAY1Cleared 510(K)
- K854029RESPIRATORY RESUSCITATION DEVICE1Cleared 510(K)
- K850248DISPOSABLE GUEDEL AIRWAY1Cleared 510(K)
- K844873PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 41Cleared 510(K)
- K842605RESPIRONICS VENT EASY OXYGEN ENRICHME1Cleared 510(K)
- K841429MOUTH TO MASK EMERGENCY VENTILATION1Cleared 510(K)
- K841120RES-Q-MATE1Cleared 510(K)
- K832512AIRWAY MASKS1Cleared 510(K)
- K833328RESPIRONICS RESCUE DOME1Cleared 510(K)
- K833482WISDOM AIRWAY1Cleared 510(K)
- K832435BROOK LIFE SAVING AIRWAY DEVICE #900 &1Cleared 510(K)
- K832471ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III1Cleared 510(K)
- K831078STRAITH ORAL AIRWAY1Cleared 510(K)
- K830767WILLIAMS AIRWAY INTUBATOR1Cleared 510(K)
- K822727RESCUER1Cleared 510(K)
- K820709AIRWAYS1Cleared 510(K)
- K821308ESPREE' GUEDEL ESPREE BERMAN AIRWAY1Cleared 510(K)
- K8205127CM BERMAN AIRWAY1Cleared 510(K)
- K812822RIND AIRWAY1Cleared 510(K)
- K810651ORAL AIRWAYS1Cleared 510(K)
- K810123THE LUOMANEN ORAL AIRWAY1Cleared 510(K)
- K810099AIRWAYS-OROPHARYNGEAL1Cleared 510(K)
- K810069STERILE AIRWAY1Cleared 510(K)
- K800881DISPOSABLE BERMAN AIRWAYS1Cleared 510(K)
- K791799CONPHAR AIRWAYS1Cleared 510(K)
- K780601AIRWAYS1Cleared 510(K)
- K770001AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S1Cleared 510(K)
- K760488AIRWAY, DUAL CHANNEL1Cleared 510(K)
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- SDSCompression-Based Airway Clearance Device2Product Code
- SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices2Product Code
- SFPVentilator-Compatible Nebulizer2Product Code
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AIRWAY MASKS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K832512
- 510(k) Type
- Traditional
- Applicant
- ARTEC ENVIRONMENTAL MONITORING DIVISION
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/1984
- Days to Decision
- 174 days