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
- 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
- K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula2Cleared 510(K)
- K203362TRACOE vario2Cleared 510(K)
- K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff2Cleared 510(K)
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set2Cleared 510(K)
- K182861Shiley Neonatal/Pediatric Tracheostomy Tube2Cleared 510(K)
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube2Cleared 510(K)
- K180034Weinmann Tracheostomy Exchange Set2Cleared 510(K)
- K172720TRACOE silcosoft Tracheostomy Tube2Cleared 510(K)
- K170720Portex Blue Line Ultra Paediatric Tracheosomy Tube2Cleared 510(K)
- K151404ProTrach Dualcare2Cleared 510(K)
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula2Cleared 510(K)
- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula2Cleared 510(K)
- K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff2Cleared 510(K)
- K133528H&H EMERGENCY CRICOTHYROTOMY KIT2Cleared 510(K)
- K133173RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET2Cleared 510(K)
- K133597CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY2Cleared 510(K)
- K122932SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT2Cleared 510(K)
- K122235RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET2Cleared 510(K)
- K123699FAHL TRACHEOSTOMY TUBES (MULTIPLE)2Cleared 510(K)
- K122531SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T2Cleared 510(K)
- K100995SHIKANI SPEAKING VALVE2Cleared 510(K)
- K093469CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS2Cleared 510(K)
- K083641BIVONA TRACHEOSTOMY TUBES2Cleared 510(K)
- K081440BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES2Cleared 510(K)
- K072582PROVOX MICRON HME2Cleared 510(K)
- K072148CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER2Cleared 510(K)
- K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA2Cleared 510(K)
- K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO2Cleared 510(K)
- K041485MARPAC MESSENGER MODEL #5012Cleared 510(K)
- K041044CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET2Cleared 510(K)
- K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA2Cleared 510(K)
- K040014PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY2Cleared 510(K)
- K030787SHILEY FLEXTRA TRACHEOSTOMY TUBE2Cleared 510(K)
- K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT2Cleared 510(K)
- K023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2Cleared 510(K)
- K022212PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS2Cleared 510(K)
- K013728TRACH VOX2Cleared 510(K)
- K014102PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 72512Cleared 510(K)
- K011210THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY2Cleared 510(K)
- K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA2Cleared 510(K)
- K000964STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL41092Cleared 510(K)
- K990905PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT2Cleared 510(K)
- K970811DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN2Cleared 510(K)
- K982128SHIKANI-FRENCH SPEAKING VALVE2Cleared 510(K)
- K972546RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET2Cleared 510(K)
- K980466PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA2Cleared 510(K)
- K973829IRRIGATION BOTTLE2Cleared 510(K)
- K972423RUSCH TRACHEOFIX-SET2Cleared 510(K)
- K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED2Cleared 510(K)
- K964056RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE2Cleared 510(K)
- K971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF2Cleared 510(K)
- K963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA2Cleared 510(K)
- K970365PASSY-MUIR O2 ADAPTER; PMA20002Cleared 510(K)
- K962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE2Cleared 510(K)
- K962714PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 20002Cleared 510(K)
- K962078TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER2Cleared 510(K)
- K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES2Cleared 510(K)
- K961449TRACHEOSTOMY TUBES TRACOE-FLEX2Cleared 510(K)
- K955564RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE2Cleared 510(K)
- K960429PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA2Cleared 510(K)
- K955680SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED2Cleared 510(K)
- K954749MALLINCKRODT SHILEY 15MM CAP2Cleared 510(K)
- K954661THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,2Cleared 510(K)
- K955516MONTGOMERY TRACHEOSTOMY SPEAKING VALVE2Cleared 510(K)
- K952700SUPERSLICK2Cleared 510(K)
- K944451PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)2Cleared 510(K)
- K945513MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K945874EUROMEDICAL POLY TRACHEOTOMY TUBE2Cleared 510(K)
- K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES2Cleared 510(K)
- K936224REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS2Cleared 510(K)
- K921733TRACHEOSTOMY CARE TRAY2Cleared 510(K)
- K936133PERCUTANEOUS TRACHEOSTOMY KIT2Cleared 510(K)
- K932016TRACHEOSTOMY CARE TRAY2Cleared 510(K)
- K933412SALINE SOLUTION-STERILE2Cleared 510(K)
- K931611PERCUTANEOUS TRACHEOSTOMY TUBE KIT2Cleared 510(K)
- K925288TRACHEOSTOMY KIT2Cleared 510(K)
- K923156TRACHEOSTOMY CARE TRAY2Cleared 510(K)
- K925020TRACHEOSTOMY CARE KIT (STERILE)2Cleared 510(K)
- K930895SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF2Cleared 510(K)
- K924243TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K925438COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT2Cleared 510(K)
- K922665BIVONA HYPERFLEX TRACHEOSTOMY TUBE2Cleared 510(K)
- K923878BIVONA CUSTOMIZED TRACHEOSTOMY TUBES2Cleared 510(K)
- K924660TRACHEOSTOMY TUBE AND TUBE CUFF2Cleared 510(K)
- K914471NEEDLECRIC2Cleared 510(K)
- K913859BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION2Cleared 510(K)
- K914183BIVONA CUFF MAINTENANCE DEVICE (CMD)2Cleared 510(K)
- K914088BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K913270BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K912967BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.2Cleared 510(K)
- K911080HYGIENA-TRACH2Cleared 510(K)
- K910362TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE2Cleared 510(K)
- K903699PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM2Cleared 510(K)
- K897102HYDRASORB(TM)2Cleared 510(K)
- K897005BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE2Cleared 510(K)
- K897059HOOD SPEAKING VALVE2Cleared 510(K)
- K896548MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE2Cleared 510(K)
- K896547MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE2Cleared 510(K)
- K894614BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE2Cleared 510(K)
- K894613BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE2Cleared 510(K)
- K894050MODIFIED DECANNULATION STOPPER2Cleared 510(K)
- K890194SHILEY SPECIALIZED TRACHEOSTOMY TUBE2Cleared 510(K)
- K885129MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE2Cleared 510(K)
- K885130MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE2Cleared 510(K)
- K812163AIRE-CUF TRACHEOSTOMY TUBE2Cleared 510(K)
- K812302SHILEY FENESTRATED LOW PRESS. CUFFED2Cleared 510(K)
- K760453REGULATOR, PRESSURE, CUFF2Cleared 510(K)
- 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
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K081440
- 510(k) Type
- Traditional
- Applicant
- SMITHS MEDICAL ASD, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/12/2008
- Days to Decision
- 113 days
- Submission Type
- Summary