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
- K083702TRACH-ASSIST1Cleared 510(K)
- K954383SURELOC CIRCUIT CONNECTOR1Cleared 510(K)
- K954197DISPOSABLE FLEX TUBE1Cleared 510(K)
- K953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS1Cleared 510(K)
- K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR1Cleared 510(K)
- K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING1Cleared 510(K)
- K944532PRIMA, INC. VENTILATOR HOSES1Cleared 510(K)
- K944535PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS1Cleared 510(K)
- K944534PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K942392AIRWAY CONNECTOR WITH FLEX TUBE1Cleared 510(K)
- K941026THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR1Cleared 510(K)
- K940793DOUBLE TRACH SWIVEL CONNECTOR1Cleared 510(K)
- K940544DOUBLE TRACH SEIVEL CONNECTOR1Cleared 510(K)
- K935821DOUBLE TRACH SWIVEL CONNECTOR1Cleared 510(K)
- K931800MAG CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K931345CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K931216CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K931038CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K931036CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K925263MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT1Cleared 510(K)
- K922537DURALIFE1Cleared 510(K)
- K924225OXYGEN SWIVEL ADAPTER (PLASTIC)1Cleared 510(K)
- K921511CATHETER MOUNTS -- MODIFICATION1Cleared 510(K)
- K921512ENTENDED LINE ACCESSORIES & CONNECTORS1Cleared 510(K)
- K913726DURALIFE(TM)1Cleared 510(K)
- K913216TRACH T ADAPTER1Cleared 510(K)
- K912652FLEX-ELBOW1Cleared 510(K)
- K911421CATHETER MOUNTS1Cleared 510(K)
- K911425ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM1Cleared 510(K)
- K911294ULTRASET CATHETER1Cleared 510(K)
- K895549M.D.I. ADAPTER1Cleared 510(K)
- K895014BAXTER BAFFLED TEE ADAPTER1Cleared 510(K)
- K894969AEROVENT1Cleared 510(K)
- K895388SHILEY ELBOW 15MM SWIVEL CONNECTOR1Cleared 510(K)
- K895144INTERTECH METERED DOSE ELBOW1Cleared 510(K)
- K884374E.T. PUFFER1Cleared 510(K)
- K881849BODAI M.D.D. ADAPTOR(TM)1Cleared 510(K)
- K882203NEOTECH UNIVERSAL ADAPTER1Cleared 510(K)
- K881230FLEX TUBE1Cleared 510(K)
- K873696BODAI NEO2-SAFE(TM)1Cleared 510(K)
- K880434MEDICOMP STRAIGHT SWIVEL ADAPTOR1Cleared 510(K)
- K873974TILSON TRACH GUARD1Cleared 510(K)
- K871737CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR1Cleared 510(K)
- K864896MEDICOMP INHALANT MASK ELBOW1Cleared 510(K)
- K865046SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE1Cleared 510(K)
- K862435DOUBLE LUMEN E T ADAPTOR1Cleared 510(K)
- K863318AEROSOL-T1Cleared 510(K)
- K862433UNI-JET CONNECTOR1Cleared 510(K)
- K860838INSPIRON DOUBLE SWIVEL TRACH ADAPTER1Cleared 510(K)
- K86065090 DEGREE ELBOW & STRAIGHT CONNECTOR1Cleared 510(K)
- K861056STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG1Cleared 510(K)
- K860878BRITISH BREATHING CIRCUIT SYSTEM1Cleared 510(K)
- K860885STRAIGHT CONNECTORS, 15MM, 30MM & 19MM1Cleared 510(K)
- K860882DISPOSABLE CATHETER1Cleared 510(K)
- K860886STRAIGHT CONNECTORS, 22MM1Cleared 510(K)
- K860887T-PIECES CONNECTORS1Cleared 510(K)
- K860888CONNECTORS/VALVE INSERT1Cleared 510(K)
- K860881CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)1Cleared 510(K)
- K860352SPACELABS AIRWAY ADAPTER SET SERIES, NO. 3690141Cleared 510(K)
- K853828FLS MED. PROD. RACINE TYPE ADAPTOR1Cleared 510(K)
- K850964DOUBLE-SWIVEL CONNECTOR1Cleared 510(K)
- K850625ARGYLE 15MM SWIVEL CONNECTOR1Cleared 510(K)
- K844656OHMEDA DOUBLE SWIVEL ADAPTER1Cleared 510(K)
- K840015SWIVEL ADAPTOR W/ALARM PORT1Cleared 510(K)
- K833373BODIA BRONCH-SAF DOUBLE SWIVEL1Cleared 510(K)
- K833372BODIA TRACH-SAF DOUBLE SWIVEL1Cleared 510(K)
- K813383DISPOSABLE TRACH SWIVEL CONNECTOR1Cleared 510(K)
- K812977RESPIRATORY CARE MONITOR1Cleared 510(K)
- K812067INSPIRATORY FORCE PRESSURE ADAPTOR1Cleared 510(K)
- K812000PEDIATRIC DOUBLE SWIVEL CONNECTOR1Cleared 510(K)
- K81192245DEGREES SWIVEL ELBOW1Cleared 510(K)
- K811890DISPOSABLE TRACH T OXYGENATOR1Cleared 510(K)
- K811708UNIVERSAL ADAPTER SYSTEM-U/ADAPIT1Cleared 510(K)
- K810621DISPOSABLE 22MM. FLEXIBLE ADAPTOR1Cleared 510(K)
- K810620DISPOSABLE ELBOW ADAPTOR1Cleared 510(K)
- K810361CONNECTOR ADAPTERS1Cleared 510(K)
- K802663BLOW-BY-SET-UP CONNECTOR-AIRWAY1Cleared 510(K)
- K791538DISPOSABLE AEROSOL T1Cleared 510(K)
- K791539DISPOSABLE 22MM ADAPTOR1Cleared 510(K)
- K791532SURELOC EXTERNAL CONNECTOR1Cleared 510(K)
- K790888TRACH T WITH ONE-WAY VALVES1Cleared 510(K)
- K790887TEE ADAPTER1Cleared 510(K)
- K790156TRACH T W/DRAINAGE BAG1Cleared 510(K)
- K790148CUFF CONNECTOR1Cleared 510(K)
- K790157TRACH T ADAPTER1Cleared 510(K)
- K790155VENTILATOR ELBOW W/SUCTION PORT1Cleared 510(K)
- K790149MASK INTULATION ADAPTOR1Cleared 510(K)
- K781759RESCAL1Cleared 510(K)
- K781395DISPOSABLE AEROSOL T BRIGGS ADAPTOR1Cleared 510(K)
- K770630ADAPTER, UNIVERSAL, BE 105-61Cleared 510(K)
- K770634ADAPTER BE 105-101 & 125-1011Cleared 510(K)
- K770587VENTILATOR ADAPTOR, #7511Cleared 510(K)
- K770585AEROSOL T ADAPTER, #7521Cleared 510(K)
- K770052VITAL-LOK TRACHEAL SWIVEL COUPLING1Cleared 510(K)
- 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
- 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
DURALIFE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K922537
- 510(k) Type
- Traditional
- Applicant
- DHD DIEMOLDING HEALTHCARE DIV.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/4/1992
- Days to Decision
- 190 days
- Submission Type
- Statement