Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—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
- K011134OXYGEN SUPPLY TUBING, MODEL 11151Cleared 510(K)
- K955656NORTH STATE PLASTICS AEROSOL TEE1Cleared 510(K)
- K943110GAS SAMPLING INTERFACES1Cleared 510(K)
- K935835BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES1Cleared 510(K)
- K931043MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS1Cleared 510(K)
- K931033MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS1Cleared 510(K)
- K913422OXYGEN TUBING, 815031Cleared 510(K)
- K914980HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES1Cleared 510(K)
- K912763OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)1Cleared 510(K)
- K905091VARIOUS MALE QUICK CONNECTS.1Cleared 510(K)
- K905094SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN1Cleared 510(K)
- K904757OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS1Cleared 510(K)
- K904701MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN1Cleared 510(K)
- K904702MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS1Cleared 510(K)
- K904337OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.1Cleared 510(K)
- K901983OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.1Cleared 510(K)
- K901961OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER1Cleared 510(K)
- K863912THE MMG 5 IN 1 CONNECTOR1Cleared 510(K)
- K860877FLEXTUBE, CONNECTING TUBING1Cleared 510(K)
- K854239OXYCOIL1Cleared 510(K)
- K853569MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING1Cleared 510(K)
- K852081PENNINE OXYGEN LINK TUBING1Cleared 510(K)
- K841901OXYMIZER FLOW RESTRICTOR1Cleared 510(K)
- K840790UNIVERSAL OXYGEN TUBING CONNECTOR1Cleared 510(K)
- K832660OXYGEN CONNECTING TUBESET-RESPIRATORY1Cleared 510(K)
- K831146OXYCOIL1Cleared 510(K)
- K831082CONNECTING TUBING1Cleared 510(K)
- K830988OXYGEN CONNECTING TUBE1Cleared 510(K)
- K823246AUSTIN INHALATOR1Cleared 510(K)
- K823142OXYGEN TUBINGS1Cleared 510(K)
- K813074CONNECTORS & ADAPTERS1Cleared 510(K)
- K813197OXYGEN CONNECTING TUBE1Cleared 510(K)
- K813234OHIO AIR ADAPTOR1Cleared 510(K)
- K811549TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR1Cleared 510(K)
- K811551TIMETER PRODUCED OHIO OXYGEN ADAPTOR1Cleared 510(K)
- K811550TIMETER PRODUCED CHEMETRON (NCG) AIR1Cleared 510(K)
- K810652TUBING CONNECTORS1Cleared 510(K)
- K810362CORRUGATED FLEX TUBING1Cleared 510(K)
- K810344OXYGEN TUBING1Cleared 510(K)
- K810374CORRUGATED FLEX TUBING #6000,1Cleared 510(K)
- K802071OXYGEN SUPPLY TUBING1Cleared 510(K)
- K801514TIMETER PRODUCED PURRITAN BENNETT O2 ADP1Cleared 510(K)
- K801261DISPOSABLE COUPLING ADAPTOR1Cleared 510(K)
- K801260DISPOSABLE PRESSURE LINE ADAPTOR1Cleared 510(K)
- K801190OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP1Cleared 510(K)
- K800664SURE FLOW TUBING1Cleared 510(K)
- K800509CONNECTING TUBES1Cleared 510(K)
- K800504OXYGEN CONNECTING TUBES1Cleared 510(K)
- K791848RESPIROMETER MANIFOLD M-5051Cleared 510(K)
- K791851RED CAP, M-5021Cleared 510(K)
- K791821CORRUGATED FLEXIBLE POLYETHYLENE & EVA1Cleared 510(K)
- K7909283-WAY T 22MM MALE1Cleared 510(K)
- K790159CORRUGATED FLEXIBLE E.V.A. TUBING1Cleared 510(K)
- K790158TUBING, E.V.A. FLEXIBLE1Cleared 510(K)
- K790147TUBING CORRUGATED1Cleared 510(K)
- K790160OXYGEN TUBING, W/VINYL AND LATEX TIPS1Cleared 510(K)
- K790150BIRD DRIVE LINE ADAPTOR1Cleared 510(K)
- K781428FLEXTUBES:9, 20, 261Cleared 510(K)
- K781416TUBING, FLEXIBLE, MEDICAL GAS1Cleared 510(K)
- K781231OXYGEN SUPPLY TUBE, DISP., PLASTIC1Cleared 510(K)
- K771075OXYGEN CONNECTING TUBE #0172051Cleared 510(K)
- K760220TUBING, SINGLE USE OXYGEN SUPPLY1Cleared 510(K)
- 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
- 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
- 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
FLEXTUBES:9, 20, 26
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K781428
- 510(k) Type
- Traditional
- Applicant
- BOURNS MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/11/1978
- Days to Decision
- 21 days