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
- K221634Oxymag - Transport and Emergency Ventilator2Cleared 510(K)
- K202219VORTRAN GO2VENT with PEEP Valve2Cleared 510(K)
- K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag2Cleared 510(K)
- K182956Puffin Lite Infant Resuscitation System2Cleared 510(K)
- K173373SafeT T-Piece Resuscitator2Cleared 510(K)
- K161420MOVES SLC2Cleared 510(K)
- K162968VORTRAN GO2VENT2Cleared 510(K)
- K141595O-TWO E700,O-TWO E600,O-TWO E5002Cleared 510(K)
- K142096T-PIECE RESUSCITATOR2Cleared 510(K)
- K140049MOVES SLC2Cleared 510(K)
- K140707LIFEBORNE INFANT RESUSCITATOR2Cleared 510(K)
- K131098EMERGENCY PORTABLE VENTILATOR2Cleared 510(K)
- K132021AHP 300, EMERGENCY PORTABLE VENTILATOR2Cleared 510(K)
- K132759VENTRAIN2Cleared 510(K)
- K131877SAVE II, SAVE II BASIC2Cleared 510(K)
- K123957PNEUPAC PARAPAC PLUS2Cleared 510(K)
- K112783MANUJET III2Cleared 510(K)
- K102542RESUSCI FLOW; RESUSCI FLOW 1042Cleared 510(K)
- K093862CAREVENT HANDHELD CPAP SYSTEM2Cleared 510(K)
- K093913MERCURY MEDICAL T-PIECE RESUSCITATOR2Cleared 510(K)
- K093261MOVES2Cleared 510(K)
- K092085ISPIRA RESUSCITATION UNIT2Cleared 510(K)
- K090356EMERGENCY PORTABLE VENTILATOR, MODEL EPV2002Cleared 510(K)
- K083507BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS2Cleared 510(K)
- K083385MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B2Cleared 510(K)
- K081330CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)2Cleared 510(K)
- K080063MASS CASUALTY VENTILATOR, MODEL MCV1002Cleared 510(K)
- K080692MACS CPAP SYSTEM2Cleared 510(K)
- K073261VAR MONITOR2Cleared 510(K)
- K072214PORTABLE VENTILATOR, MODEL EPV-1002Cleared 510(K)
- K071527PNEUPAC VR1 AIR MIX2Cleared 510(K)
- K071221SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X122Cleared 510(K)
- K070636AUTOVENT 4000 WITH CPAP2Cleared 510(K)
- K070120AUTOVENT MODEL 40002Cleared 510(K)
- K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM2Cleared 510(K)
- K051476UNI-VENT MODEL 73X2Cleared 510(K)
- K051469CAREVENT ATV+ AND CAREVENT MRI2Cleared 510(K)
- K051889CAREVENT CA AND DRA2Cleared 510(K)
- K051322PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS2Cleared 510(K)
- K043495BABYPAC2Cleared 510(K)
- K041473VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM2Cleared 510(K)
- K040090COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)2Cleared 510(K)
- K032386UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)2Cleared 510(K)
- K030803PARAPAC 200D TRANSPORT, MODEL V200D2Cleared 510(K)
- K021841COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER2Cleared 510(K)
- K020899PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D2Cleared 510(K)
- K021520EMT-CPAP2Cleared 510(K)
- K001430RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 20002Cleared 510(K)
- K991785MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR2Cleared 510(K)
- K991195CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV2Cleared 510(K)
- K983857AUTOVENT 15002Cleared 510(K)
- K983785AUTOVENT 10002Cleared 510(K)
- K983705EMT RESUSCITATOR2Cleared 510(K)
- K983643GENESIS BLS2Cleared 510(K)
- K982225SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 5042Cleared 510(K)
- K973975RESPIRTECHPRO2Cleared 510(K)
- K960515PARAPAC2Cleared 510(K)
- K944349OXYLATOR EM-1002Cleared 510(K)
- K951126DRAGER MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K944397BNOS MICROVENT, MODEL AC AND MODEL AO2Cleared 510(K)
- K941871LSPI AUTOMATIC VENTILATOR, MODEL AV3000-1002Cleared 510(K)
- K941870LSPI AUTOMATIC VENTILATOR, MODEL AV2000-1002Cleared 510(K)
- K931473IMPACT MODEL 7532Cleared 510(K)
- K924272MEDIRESP III2Cleared 510(K)
- K932199LSPI AUTOMATIC VENTILATOR, MODEL AV30002Cleared 510(K)
- K932200LSPI AUTOMATIC VENTILATOR2Cleared 510(K)
- K932170FLYNNR GENESIS II A/C, A/O AND IDLH2Cleared 510(K)
- K920910OXYGEN POWERED RESUSCITATOR FOR CPR2Cleared 510(K)
- K921926JET VENTILATOR/JETTING DEVICE2Cleared 510(K)
- K913039FLLYNN(R) GENESIS AC2Cleared 510(K)
- K915564SPIROS2Cleared 510(K)
- K910699LIFE-02 (NON-REFILLABLE CYLINDER)2Cleared 510(K)
- K910434LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL2Cleared 510(K)
- K910435LIFE OXYGENPAC 6/12 LPM2Cleared 510(K)
- K911261ERA 2000A2Cleared 510(K)
- K904920AMBU MATIC AUTOMATIC RESUSCITATOR2Cleared 510(K)
- K910201LIFE O22Cleared 510(K)
- K905697POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE2Cleared 510(K)
- K901846OHMEDA - LOGIC 07A TRANSPORT VENTILATOR2Cleared 510(K)
- K895946BIVONA CARDEN INTERMITTENT JETTING DEVICE2Cleared 510(K)
- K892885RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR2Cleared 510(K)
- K884089ERA 2000 EMERGENCY RESUSCITATOR2Cleared 510(K)
- K882833THE BERG RESUSCITATION APPARATUS2Cleared 510(K)
- K870424LSP AUTOMATIC VENTILATOR, MODEL 4562Cleared 510(K)
- K874656AUTOMATIC VENTILATOR AV20002Cleared 510(K)
- K863410PATIENT VALVE WITH AIR ENTRAINMENT2Cleared 510(K)
- K862830MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR2Cleared 510(K)
- K862192RESUSCITATOR MODELS 10400/10500/10600/10700/108002Cleared 510(K)
- K861272IMPACT MODELS 701, 702 AND 7032Cleared 510(K)
- K860077SG-066 OXYGEN ENRICHMENT KIT2Cleared 510(K)
- K855092LIFE CORP. OXYGEN PAC2Cleared 510(K)
- K853971REGULATOR-INHALATOR SYSTEM2Cleared 510(K)
- K851337502 RESUSCITATORY INHALATOR VALVE2Cleared 510(K)
- K841893MAXAMAN2Cleared 510(K)
- K830404RAD VALVE2Cleared 510(K)
- K800456EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.2Cleared 510(K)
- K792453PNEUPAC OXYGEN THERAPY UNIT2Cleared 510(K)
- K780168PARAMEDIC O2 KIT2Cleared 510(K)
- K771299EMERGENCY OXYGEN RESUSCITATOR2Cleared 510(K)
- 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
- 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
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K982225
- 510(k) Type
- Traditional
- Applicant
- SPIRACLE TECHNOLOGY
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/28/1998
- Days to Decision
- 126 days
- Submission Type
- Summary