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
- K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)2Cleared 510(K)
- K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)2Cleared 510(K)
- K211543Wei Nasal Jet Tube2Cleared 510(K)
- K213028Tenax Laser Resistant Endotracheal Tube2Cleared 510(K)
- K200761Tenax Laser Resistant Endotracheal Tube2Cleared 510(K)
- K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm2Cleared 510(K)
- K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff2Cleared 510(K)
- K182739Endotracheal Tube with Evacuation Lumen2Cleared 510(K)
- K192324Sheridan Spiral-Flex Endotracheal Tubes2Cleared 510(K)
- K190630SolidAIRity III Airway Stabilization System2Cleared 510(K)
- K190213Yikang Endotracheal Tube2Cleared 510(K)
- K190274Endotracheal Tube2Cleared 510(K)
- K181880VivaSight-SL (TVT) system2Cleared 510(K)
- K171917Frova Intubating Introducer2Cleared 510(K)
- K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet2Cleared 510(K)
- K170234Endotracheal tube; Reinforced Endotracheal tube2Cleared 510(K)
- K171411IRRIS (Infra-Red-Red Intubation System)2Cleared 510(K)
- K161813Frova Intubating Introducer2Cleared 510(K)
- K160694Disposable Endotracheal tube, sterile, AccuCuff2Cleared 510(K)
- K152438ETView VivaSight-SL (TVT) system2Cleared 510(K)
- K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye2Cleared 510(K)
- K150603Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube2Cleared 510(K)
- K141747RHINOGUARD2Cleared 510(K)
- K140228DISPOSABLE TRACHEAL TUBE2Cleared 510(K)
- K141939TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET2Cleared 510(K)
- K132415RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE2Cleared 510(K)
- K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE2Cleared 510(K)
- K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING2Cleared 510(K)
- K111406BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)2Cleared 510(K)
- K111401BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE2Cleared 510(K)
- K121028ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))2Cleared 510(K)
- K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS2Cleared 510(K)
- K110962AMBU ASCOPE 22Cleared 510(K)
- K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL2Cleared 510(K)
- K100546PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE2Cleared 510(K)
- K093186AMBU ASCOPE AND MONITOR2Cleared 510(K)
- K093135VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE2Cleared 510(K)
- K091761TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT2Cleared 510(K)
- K090777EZC MEDICAL, LLC INTUBAIDFLEX2Cleared 510(K)
- K083119PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.52Cleared 510(K)
- K091591FLEXICARE MEDICAL ENDOTRACHEAL TUBES2Cleared 510(K)
- K082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V2Cleared 510(K)
- K090352TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES2Cleared 510(K)
- K080105ENDOTRACHEAL TUBE2Cleared 510(K)
- K080339MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)2Cleared 510(K)
- K082420TRACHEOSCOPIC VENTILATION TUBE (TVT)2Cleared 510(K)
- K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES2Cleared 510(K)
- K081086PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.02Cleared 510(K)
- K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBE2Cleared 510(K)
- K080821MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE2Cleared 510(K)
- K080170AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)2Cleared 510(K)
- K071365AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE2Cleared 510(K)
- K060094ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES2Cleared 510(K)
- K052233TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM2Cleared 510(K)
- K051993LMA FASTRACH ETT SINGLE USE2Cleared 510(K)
- K050785AMSINO ENDOTRACHEAL TUBE2Cleared 510(K)
- K050803PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES2Cleared 510(K)
- K041311TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)2Cleared 510(K)
- K042683WELL LEAD ENDOTRACHEAL TUBE2Cleared 510(K)
- K043205RUSCH EASY TUBE2Cleared 510(K)
- K041917PLASIATEK ACTUATOR2Cleared 510(K)
- K040657BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/802Cleared 510(K)
- K031794ENDOFLEX TRACHEAL TUBE2Cleared 510(K)
- K032112P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)2Cleared 510(K)
- K030792BARD ENDOTRACHEAL TUBE, CUFFED2Cleared 510(K)
- K023964RUSCH MICROLARYNGEAL TUBE2Cleared 510(K)
- K021044MADETT2Cleared 510(K)
- K021540RUSCH EDGAR TUBE2Cleared 510(K)
- K013321SILICONE TRACHEAL T-TUBES2Cleared 510(K)
- K000045POSITUBE2Cleared 510(K)
- K991580ILM ENDOTRACHEAL TUBE2Cleared 510(K)
- K993786RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY2Cleared 510(K)
- K993582MODIFICATION TO LASER-SHIELD II2Cleared 510(K)
- K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE2Cleared 510(K)
- K984528PARKER FLEX-TIP TRACHEAL TUBE2Cleared 510(K)
- K990556ESOPHAGEAL INTUBATION DETECTOR2Cleared 510(K)
- K990098VENTLAB VERIFY II2Cleared 510(K)
- K981891AMBU TUBECHECK2Cleared 510(K)
- K971759MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER2Cleared 510(K)
- K973191THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM2Cleared 510(K)
- K970196T-WALL UNCUFFED TRACHEAL TUBE2Cleared 510(K)
- K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES2Cleared 510(K)
- K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE2Cleared 510(K)
- K962098ESOPHAGEAL INTUBATION DETECTOR2Cleared 510(K)
- K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY2Cleared 510(K)
- K961840RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY2Cleared 510(K)
- K955495RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE2Cleared 510(K)
- K960795VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE2Cleared 510(K)
- K954585RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE2Cleared 510(K)
- K960450HEBELER SAFE-T-TUBE2Cleared 510(K)
- K951768TEVES ECM PLUS THERMOCOUPLE2Cleared 510(K)
- K954754WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE2Cleared 510(K)
- K954753PEDIATRIC SILICONE ENDOTRACHEAL TUBE2Cleared 510(K)
- K954751SILICONE ENDOTRACHEAL TUBE2Cleared 510(K)
- K954750PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE2Cleared 510(K)
- K953368LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES2Cleared 510(K)
- K935842RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE2Cleared 510(K)
- K952013PRIMA GUEDEL AIRWAYS2Cleared 510(K)
- K951696ENDOTRACHEAL TUBE2Cleared 510(K)
- K951697PEDIATRIC ENDOTRACHEAL TUBE2Cleared 510(K)
- K924997EDD2Cleared 510(K)
- K945816QUICK-LOCK2Cleared 510(K)
- K945455GENERAL ANESTHESIA SYSTEM2Cleared 510(K)
- K945745ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)2Cleared 510(K)
- K944324SURE-LOCK VENTILATOR TUBING HOLDER2Cleared 510(K)
- K942628ESOPHAGEAL INTUBATION DETECTOR BULB2Cleared 510(K)
- K940041COLIBRI2Cleared 510(K)
- K941969ENDOPLUS2Cleared 510(K)
- K941246RAE II TRACHEAL TUBE2Cleared 510(K)
- K934465DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE2Cleared 510(K)
- K932647WIRE REINFORCED ENDOTRACHEAL TUBE2Cleared 510(K)
- K934117STABILTUBE2Cleared 510(K)
- K933398BIVONA ILLUMINATED ENDOTRACHEAL TUBE2Cleared 510(K)
- K925508RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP2Cleared 510(K)
- K925507RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP2Cleared 510(K)
- K925505RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE2Cleared 510(K)
- K931749BIVONA(R) ICU ENDOTRACHEAL TUBE2Cleared 510(K)
- K930741ESOPHAGEAL INTUBATION DETECTOR2Cleared 510(K)
- K925506RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE2Cleared 510(K)
- K932711PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS2Cleared 510(K)
- K932561GUEDEL AIRWAYS2Cleared 510(K)
- K932280RAE(R) II TRACHEAL TUBE2Cleared 510(K)
- K931164RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY2Cleared 510(K)
- K931163RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE2Cleared 510(K)
- K931165RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE2Cleared 510(K)
- K931166RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY2Cleared 510(K)
- K931735BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE2Cleared 510(K)
- K922894LAZER-TRACH TRACHEAL TUBE2Cleared 510(K)
- K925781DISPOSABLE CUFFED ENDOTRACHEAL TUBE2Cleared 510(K)
- K922880XOMED TREACE JET VENTILATION TUBE2Cleared 510(K)
- K926498ENDOGRIP2Cleared 510(K)
- K930114TRACHEOSTOMY T-TUBE2Cleared 510(K)
- K923591PALA-NATE2Cleared 510(K)
- K930179TRACHEAL TUBE FIXATION DEVICE2Cleared 510(K)
- K925855DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE2Cleared 510(K)
- K930150SAFE-T-TUBE RADIOPAQUE2Cleared 510(K)
- K914370MECONIUM SUCTION DEVICE (MSD)2Cleared 510(K)
- K921077DISPOSABLE INTUBATION KITS2Cleared 510(K)
- K910463MEROCEL(R) LASER-GUARD(TM)2Cleared 510(K)
- K915277ENDOTRACHEAL CPAP SET2Cleared 510(K)
- K920900POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES2Cleared 510(K)
- K915799BIVONA SLEEP APNEA TUBE2Cleared 510(K)
- K912290HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))2Cleared 510(K)
- K902193KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP2Cleared 510(K)
- K903876MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)2Cleared 510(K)
- K900457CUFFED LINDER NASOTRACHEAL AIRWAY2Cleared 510(K)
- K896181APT TRACHEA TUBES2Cleared 510(K)
- K893609TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)2Cleared 510(K)
- K895132CONNELL-STEPHENS ENDO ANESS TUBE2Cleared 510(K)
- K894669LASER SHIELDING TUBE2Cleared 510(K)
- K892432KENDALL CURITY ENDOTRACHEAL TUBES2Cleared 510(K)
- K883096TRACHEAL TUBE LASER SHIELD KIT2Cleared 510(K)
- K881496LINDER NASOTRACHEAL AIRWAY2Cleared 510(K)
- K881313IQK-2002Cleared 510(K)
- K880487NEOTECH MECONIUM ASPIRATOR (STERILE)2Cleared 510(K)
- K880960NDYAG LASER TRACHEAL TUBE2Cleared 510(K)
- K874679TRACHEAL TUBE LASER SHIELD KIT2Cleared 510(K)
- K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)2Cleared 510(K)
- K871632NASOGASTRIC VOICETUBE2Cleared 510(K)
- K872366AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE2Cleared 510(K)
- K872616BELL/MCKAY TRACHEAL TUBE2Cleared 510(K)
- K871263MULTIPLE PHARMA-PLAST TRACHEAL TUBE2Cleared 510(K)
- K870470TRACH MATE TRACHEAL TUBE2Cleared 510(K)
- K870387EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE2Cleared 510(K)
- K871204CUFFED TRACHEAL TUBE (MULTIPLE)2Cleared 510(K)
- K864533HOOD BIFURCATED T-TUBE2Cleared 510(K)
- K864161TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER2Cleared 510(K)
- K862950WHITE-SIPOSS TUBE, CAT NO WS-12Cleared 510(K)
- K862238BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE2Cleared 510(K)
- K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)2Cleared 510(K)
- K862347ENDOTRACHEAL TUBE, ACCESSORY2Cleared 510(K)
- K860901LASER RESISTANT TRACHEAL TUBE (TENTATIVE)2Cleared 510(K)
- K861463SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE2Cleared 510(K)
- K861462SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE2Cleared 510(K)
- K861461SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE2Cleared 510(K)
- K861454END TIDAL CO2 TUBE2Cleared 510(K)
- K860105SPIRAL-FLEX2Cleared 510(K)
- K854632ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE2Cleared 510(K)
- K853502VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY2Cleared 510(K)
- K852025BRANDT TRACHEAL TUBE(TENTATIVE)2Cleared 510(K)
- K852493UNCUFFED HI-LO JET TRACHEAL TUBE2Cleared 510(K)
- K844696TROGIDE2Cleared 510(K)
- K843988S.E.T. TUBE2Cleared 510(K)
- K844564ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE2Cleared 510(K)
- K844746TRACHEAL TUBE W/AIRWAY INTUBATOR2Cleared 510(K)
- K843936MONTGOMERY SAFE-T-TUBE2Cleared 510(K)
- K844296TRACHEAL TUBE, REINFORCED, CUFFED2Cleared 510(K)
- K843714DOUBLE CONTOURED CUFF TRACHEAL TUBE2Cleared 510(K)
- K841872UNCUFFED REINFORCED TRACHEAL TUBE2Cleared 510(K)
- K842635SHERIDAN/ENDO-PAK2Cleared 510(K)
- K842558SHERIDAN/INTENSA TUBE2Cleared 510(K)
- K842464TRACHEAL TUBE/STETHOSCOPE2Cleared 510(K)
- K840943ENDO-JECT2Cleared 510(K)
- K840973COLE TUBE-LATEX2Cleared 510(K)
- K8338313-DAY BIOINDICATOR RELEASE FOR STERIL2Cleared 510(K)
- K833807ARGYLE JET TRACHEAL TUBE2Cleared 510(K)
- K833197TRACH SWIVE/CONNECTOR2Cleared 510(K)
- K832629INTUBATION KIT2Cleared 510(K)
- K830631TRACHEAL TUBE W/ILLUMINATING LOCATER2Cleared 510(K)
- K823757SURGITEK ENDOTRACHEAL TUBE, LASER RESIS2Cleared 510(K)
- K830504SURGITEK ULTRA-LO CUFF2Cleared 510(K)
- K830352REINFORCED SILICONE TRACHEAL TUBE2Cleared 510(K)
- K822082SHERIDAN/HVT,CF, UNCUFFED2Cleared 510(K)
- K821670ARGYLE TARTAN I TRACHEAL TUBE2Cleared 510(K)
- K821456ENDOTRACHEAL TUBE2Cleared 510(K)
- K821243ENDOTRACHEAL TUBE2Cleared 510(K)
- K821180TRACELON2Cleared 510(K)
- K821027SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL2Cleared 510(K)
- K813373VYGON ENDOTRACHEAL TUBES2Cleared 510(K)
- K812880OHIO NON-REUSABLE TRACHEAL TUBE MAJILL2Cleared 510(K)
- K812879OHIO NON-REUSABLE TRACHEAL TUBE MURPHY2Cleared 510(K)
- K812943SLICK ENDOTRACHEAL TUBE2Cleared 510(K)
- K811937ARGYLE TARTAN TRACHEAL TUBE2Cleared 510(K)
- K811888LINDHOLM ANATOMICAL TRACHEAL TUBE2Cleared 510(K)
- K810763OHIO DISPOSABLE TRACHEAL TUBE2Cleared 510(K)
- K802505DOUBLE LUMEN TRACHEAL TUBE2Cleared 510(K)
- K810151SLICK SET W/SURELOC EXTERNAL CONNECTOR2Cleared 510(K)
- K801213CONCEPT ENDOTRACHEAL TUBE2Cleared 510(K)
- K801005MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)2Cleared 510(K)
- K800634OHIO DISPOSABLE TRACHEAL TUBE2Cleared 510(K)
- K792035FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE2Cleared 510(K)
- K791045MODEL GV-10 LANZ PRESSURE-VALVE2Cleared 510(K)
- K791046ENDOTRACHEAL TUBES, LONG & SHORT TERM2Cleared 510(K)
- K790927OXYGENERATOR NO. M-0492Cleared 510(K)
- K790575TUBE, ARMORED TRACHEAL2Cleared 510(K)
- K790312ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR2Cleared 510(K)
- K781713ADAPTER, C/D SUCTION2Cleared 510(K)
- K781808SLICK SET, CUFFED2Cleared 510(K)
- K781339ENDOTRACHEAL TUBE2Cleared 510(K)
- K780900SLICK SET2Cleared 510(K)
- K780583FOME-CUF PVC2Cleared 510(K)
- K771197NORTON ENDOTRACHEAL2Cleared 510(K)
- K760998ENDOTRACHAEL TUBE AND HOLDER2Cleared 510(K)
- 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
- 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
3-DAY BIOINDICATOR RELEASE FOR STERIL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K833831
- 510(k) Type
- Traditional
- Applicant
- SHILEY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/21/1984
- Days to Decision
- 135 days