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
- K233713Pilling Tracheostomy Tubes2Cleared 510(K)
- K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm2Cleared 510(K)
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube2Cleared 510(K)
- K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)2Cleared 510(K)
- K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA2Cleared 510(K)
- K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE2Cleared 510(K)
- K100480ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH2Cleared 510(K)
- K100283VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC2Cleared 510(K)
- K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT2Cleared 510(K)
- K073702PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR2Cleared 510(K)
- K062104TALKING TRACH2Cleared 510(K)
- K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KIT2Cleared 510(K)
- K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 4702Cleared 510(K)
- K050379CS MEDICAL ADULT TTCF CATHETER2Cleared 510(K)
- K042684WELL LEAD TRACHEOSTOMY TUBE2Cleared 510(K)
- K031553SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES2Cleared 510(K)
- K030570BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE2Cleared 510(K)
- K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA2Cleared 510(K)
- K021764RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED2Cleared 510(K)
- K983000CRICOTHYROTOMY TUBE2Cleared 510(K)
- K981080SCOOP 12Cleared 510(K)
- K955461TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).2Cleared 510(K)
- K960205CPR TRACHEOTOMY CARE TRAY2Cleared 510(K)
- K962240MOORE TRACHEOSTOMY TUBE2Cleared 510(K)
- K953559LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)2Cleared 510(K)
- K952416TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K945406SSV PHONATE(TM) SHILEY SPEAKING VALVE2Cleared 510(K)
- K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT2Cleared 510(K)
- K941470TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K924193TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)2Cleared 510(K)
- K924191TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL2Cleared 510(K)
- K924194TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)2Cleared 510(K)
- K924195TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES2Cleared 510(K)
- K923834TRACHEOSTOMY CARE SET WITH GLOVES2Cleared 510(K)
- K925249CMI STOMA COVERS2Cleared 510(K)
- K922749LOW PROFILE TRACHEOSTOMY TUBE2Cleared 510(K)
- K921281TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K920281TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE2Cleared 510(K)
- K920604BIVONA TRACHEAL T-TUBE STENT2Cleared 510(K)
- K914743EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF2Cleared 510(K)
- K912124TRACHEOSTOMY TUBE AND CUFF2Cleared 510(K)
- K912469BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K903730D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES2Cleared 510(K)
- K901920PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K902281MODIFIED SCOOP TRANSTRACHEAL CATHETERS2Cleared 510(K)
- K901079SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER2Cleared 510(K)
- K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE2Cleared 510(K)
- K900548SHILEY PHONATION VALVE2Cleared 510(K)
- K894096STAT-TRACH(TM) VENTILATION CATHETER2Cleared 510(K)
- K896798TRACHEOSTOMY TRAY2Cleared 510(K)
- K895162TRAUMAFUSE TRACH SHIELD2Cleared 510(K)
- K895130HEIMLICH MICRO TRACH2Cleared 510(K)
- K893866HOOD PEDIATRIC TRACHEOSTOMY TUBE2Cleared 510(K)
- K885139MODIFIED ADULT CRICOTHYROIDOTOMY KIT2Cleared 510(K)
- K890342AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)2Cleared 510(K)
- K884730SHILEY PERC TRACHEOSTOMY SYSTEM2Cleared 510(K)
- K884015PREMIER DECANNULATION STOPPER2Cleared 510(K)
- K884427FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.2Cleared 510(K)
- K882430HOOD TRACHEAL STOMA BUTTON2Cleared 510(K)
- K880614SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE2Cleared 510(K)
- K880317PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP2Cleared 510(K)
- K880316PREFILLED WATER FOR IRRIGATION USP2Cleared 510(K)
- K874450SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT2Cleared 510(K)
- K880247MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES2Cleared 510(K)
- K874742QUICKTRACH2Cleared 510(K)
- K873499TODD MEDICAL/SKILLED CARE PRODUCTS2Cleared 510(K)
- K872486LARKEL DEVICE W/ATTACHMENTS A-H2Cleared 510(K)
- K871199MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.2Cleared 510(K)
- K870181JOHNSON INTRATRACHEAL OXYGEN CATHETER SET2Cleared 510(K)
- K865061SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE2Cleared 510(K)
- K862436TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)2Cleared 510(K)
- K862909RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM2Cleared 510(K)
- K862167MINI-TRACH KIT2Cleared 510(K)
- K862267FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES2Cleared 510(K)
- K861645MICRO-TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K853051TRACHEAL TUBES2Cleared 510(K)
- K855130TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K854252TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER2Cleared 510(K)
- K860176LARYNGECTOMY TUBE, CUFFED2Cleared 510(K)
- K853511THE HOOD LIFE SAVER2Cleared 510(K)
- K853419CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE2Cleared 510(K)
- K852413LGT TUBE2Cleared 510(K)
- K852272BIVONA TRACHEOSTOMA VALVE II2Cleared 510(K)
- K851016PASSY-MUIR TRACH VALVE2Cleared 510(K)
- K851462BFW VOICE GENERATOR2Cleared 510(K)
- K850456TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K850445TRACHEOSTOMY CARE TRAY2Cleared 510(K)
- K850446TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K843785WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR2Cleared 510(K)
- K843729SHILEY DISPOS. CANNULA FENESTRATED LOW2Cleared 510(K)
- K843730SHILEY DISPOS. DECANNULATION PLUG W/SW/2Cleared 510(K)
- K822440PERCUTANEOUS CRICOTHYROIDOTOMY2Cleared 510(K)
- K832466TRACHEAL TUBE 16 GAUGE-1.65MM-2Cleared 510(K)
- K842415ALL-HANDS TRACHEOSTOMY CARE SET 01012Cleared 510(K)
- K841266MONTGOMERY TRACHEAL T-TUBE2Cleared 510(K)
- K840925PEDIA-TRAKE CRICOTHYROTOMY KIT2Cleared 510(K)
- K841546COMMUNI-TRACH TUBE2Cleared 510(K)
- K8338323-DAY BIOINDICATOR RELEASE FOR RESPIR2Cleared 510(K)
- K840539DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY2Cleared 510(K)
- K834179H.R. JAKOBI SURG. INSTRUMENTS #9 482Cleared 510(K)
- K832498PERCUTANEOUS TRACHEOSTOMY DEVICE2Cleared 510(K)
- K831720ARGYLE SILICONE TRACHESTOMY TUBE W/LOW2Cleared 510(K)
- K831511TRACHEOSTOMY TUBE2Cleared 510(K)
- K830509EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-2Cleared 510(K)
- K823291COMMUNITRACH TUBE2Cleared 510(K)
- K822811CONTAINERS OF STERILE WATER OS SALINE2Cleared 510(K)
- K822295SURGI TEK'S DISPOS. INNER CANNULA FOR2Cleared 510(K)
- K820099TRACH TAPE2Cleared 510(K)
- K811447SHILEY DISPOSABLE CANNULA TRACH. TUBE2Cleared 510(K)
- K811033SHILEY LOW PRESSURE THIN-CUFFED TRACH2Cleared 510(K)
- K810978MONTGOMERY SILICONE TRACHEAL T-TUBE2Cleared 510(K)
- K810575MARTIN TRACH-SECURE2Cleared 510(K)
- K810436TRACHEOSTOMA VENT2Cleared 510(K)
- K810321REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)2Cleared 510(K)
- K810106SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE2Cleared 510(K)
- K802916MONTG. TRACHEAL CANNULA2Cleared 510(K)
- K801379CUFFED TRACHEA TUBE FOR USE W/PERTRACH2Cleared 510(K)
- K801931MARTIN TRACH-SECURE2Cleared 510(K)
- K792069TRACHEOSTOMY CARE KIT2Cleared 510(K)
- K790930TRACHE FITTING M-3072Cleared 510(K)
- K791044TRACHEOSTOMY TUBES, SHORT AND LONG TERM2Cleared 510(K)
- K790437TRACH CARE KIT2Cleared 510(K)
- K781729TRACHEOTOMY TUBES2Cleared 510(K)
- K772138ENDOTRACHEAL TUBE2Cleared 510(K)
- K770218SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE2Cleared 510(K)
- K761258DOVER LOW PRESSURE TRACHEAL TUBE2Cleared 510(K)
- K761190TRACHEOSTOMY CARE KIT2Cleared 510(K)
- 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
- 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
- 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
SSV PHONATE(TM) SHILEY SPEAKING VALVE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K945406
- 510(k) Type
- Traditional
- Applicant
- MALLINCKRODT MEDICAL TPI, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/27/1995
- Days to Decision
- 116 days
- Submission Type
- Summary