Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use 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
- CAHFilter, Bacterial, Breathing-Circuit2Product Code
- K241339Besmed Bacterial Filter and HMEF2Cleared 510(K)
- K222917Breathing circuit bacterial/viral filter2Cleared 510(K)
- K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2Cleared 510(K)
- K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)2Cleared 510(K)
- K221472Filter and HME/Filter2Cleared 510(K)
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus2Cleared 510(K)
- K221250EasyOne Filter2Cleared 510(K)
- K210352GGM Breathing Circuit Bacterial Filter2Cleared 510(K)
- K211286Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger2Cleared 510(K)
- K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter2Cleared 510(K)
- K191909HepaShield Bacterial Viral Breathing System Filter2Cleared 510(K)
- K192713Altera Filter and HME/Filter2Cleared 510(K)
- K182862Servo Guard2Cleared 510(K)
- K190022SafeBreath Filter Mouthpiece2Cleared 510(K)
- K163300ThermoShield HME Filter2Cleared 510(K)
- K151498Breathing circuit bacterial/viral filter2Cleared 510(K)
- K141087INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF2Cleared 510(K)
- K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER2Cleared 510(K)
- K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER2Cleared 510(K)
- K131626EXCELERON BACTERIAL FILTERS2Cleared 510(K)
- K133666RT016 INSPIRATORY FILTER2Cleared 510(K)
- K130664HYRDROMAX HMEF2Cleared 510(K)
- K121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]2Cleared 510(K)
- K121026FLO-GUARD BREATHING FILTER2Cleared 510(K)
- K112958HUMID-VENT HEPA2Cleared 510(K)
- K110246MEDISIZE RED AND MEDISIZE BLUE2Cleared 510(K)
- K111408MICROGARD II2Cleared 510(K)
- K102483SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 1042Cleared 510(K)
- K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER2Cleared 510(K)
- K101629FIL 15202Cleared 510(K)
- K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER2Cleared 510(K)
- K093426BACT-TRAP HEPA MIDI2Cleared 510(K)
- K091363COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER2Cleared 510(K)
- K092218FLEXICARE BREATHING FILTERS2Cleared 510(K)
- K090738THERMOFLO HCH, THERMOFLO FILTER2Cleared 510(K)
- K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER2Cleared 510(K)
- K081536MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED2Cleared 510(K)
- K072002FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 552Cleared 510(K)
- K063526A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER2Cleared 510(K)
- K063125FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)2Cleared 510(K)
- K061426OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF472Cleared 510(K)
- K052087BREATHING FILTER BACTERIAL/VIRAL, MODEL AG71782Cleared 510(K)
- K050927RT019 INSPIRATORY/EXPIRATORY FILTER2Cleared 510(K)
- K050953AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE2Cleared 510(K)
- K043120MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER2Cleared 510(K)
- K043148ALL FLOW PULMONARY FUNCTION FILTER2Cleared 510(K)
- K032878KUNG SHIN, HMEF SK2032Cleared 510(K)
- K033008AIR SAFETY HEPA AND NON-HEPA FILTERS2Cleared 510(K)
- K032322CLEAR-THERM MICRO HME, MODEL 14412Cleared 510(K)
- K030071SERVO GUARD, MODEL 64 81 290 EH88E2Cleared 510(K)
- K032716PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)2Cleared 510(K)
- K030271VENTLAB BACTERIAL FILTER, MODEL BF1002Cleared 510(K)
- K030990DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR2Cleared 510(K)
- K024270CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F32Cleared 510(K)
- K031653DATEX-OHMEDA HMEF 7502Cleared 510(K)
- K023641DATEX-OHMEDA HMEF MINI2Cleared 510(K)
- K021265DATEX-OHMEDA HMEF 5002Cleared 510(K)
- K013093PALL ULTIPOR ANESTHESIA BREATHING SYSTEM2Cleared 510(K)
- K014282BACSTOP FILTER,BACSTOP FILTER/HME2Cleared 510(K)
- K014281GARD FILTER, COMBIGARD FILTE / HME2Cleared 510(K)
- K021020TERUMO GAS FILTER2Cleared 510(K)
- K013122EMS ELECTROSTATIC FLITER AND HME COMBINATION2Cleared 510(K)
- K013089EMS HEPA FILTER AND HME COMBINATIONS2Cleared 510(K)
- K012958BREATHING CIRCUIT FILTER2Cleared 510(K)
- K011212FILTERFLO H2Cleared 510(K)
- K013200RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/012Cleared 510(K)
- K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE2Cleared 510(K)
- K002839END EXPIRATORY FILTER, MODEL RT0202Cleared 510(K)
- K011132AIRLIFE HEPA FILTER2Cleared 510(K)
- K010040SLEEVED FILTER2Cleared 510(K)
- K002201ELECTROSTATIC HYDROPHOBIC BREATHING FILTER2Cleared 510(K)
- K002506BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT2Cleared 510(K)
- K000654VBMAX2Cleared 510(K)
- K990949CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT2Cleared 510(K)
- K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,182Cleared 510(K)
- K983817BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)2Cleared 510(K)
- K980662LICHEN, BACTERIAL IN LINE BREATHING FILTER2Cleared 510(K)
- K982239CIRCUIT GUARD2Cleared 510(K)
- K982127POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER2Cleared 510(K)
- K973797BREATHING CIRCUIT BACTERIAL FILTER2Cleared 510(K)
- K97463072 HOUR USE TRACH CARE WITH MICROBAN2Cleared 510(K)
- K973238ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER2Cleared 510(K)
- K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)2Cleared 510(K)
- K973314SPIROSAFE FILTER2Cleared 510(K)
- K970102FILTER2Cleared 510(K)
- K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)2Cleared 510(K)
- K965020POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER2Cleared 510(K)
- K964979POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER2Cleared 510(K)
- K9630539000 SERIES FILTER & FILTER/HME2Cleared 510(K)
- K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT2Cleared 510(K)
- K964204ENGSTROM HMEF 10002Cleared 510(K)
- K961838RESPIRGARD II, SPIROGARD2Cleared 510(K)
- K954490MERCURY MEDICAL CPR BAG EXHALATION FILTER2Cleared 510(K)
- K961914BACTERIA/VIRAL FILTER2Cleared 510(K)
- K954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT2Cleared 510(K)
- K953687WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER2Cleared 510(K)
- K952428POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER2Cleared 510(K)
- K952062PFT FILTER2Cleared 510(K)
- K951047BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA2Cleared 510(K)
- K952015PRIMA FILTER2Cleared 510(K)
- K951484WESTMED BACTERIAL/VIRAL FILTER2Cleared 510(K)
- K951410DISPOSABLE PULMONARY FUNCTION FILTER2Cleared 510(K)
- K915750DISPOSABLE BACTERIAL BREATHNG FILTER2Cleared 510(K)
- K945543GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE2Cleared 510(K)
- K944189TRANSPARENT ANESTHESIA FILTER2Cleared 510(K)
- K943874PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS2Cleared 510(K)
- K934132POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER2Cleared 510(K)
- K944124SPIROBAC ADAPTERS2Cleared 510(K)
- K941676STERIVENT AND STERIVENT S2Cleared 510(K)
- K941536BARRIERBAC AND BARRIERBAC S2Cleared 510(K)
- K941381HYGROBAC,S HYGROBOY AND HYGROBABY2Cleared 510(K)
- K934272SENSORMEDICS MICROGARD MICROBIAL FILTER2Cleared 510(K)
- K934189BARRIERFLEX-I, AND BARRIERFLES-II2Cleared 510(K)
- K934475KOKO FILTER II2Cleared 510(K)
- K934509PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER2Cleared 510(K)
- K934540BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER2Cleared 510(K)
- K930816HEPA FILTERED HME2Cleared 510(K)
- K925462BREATHING FILTERS 1942T/1941T/2014T2Cleared 510(K)
- K931842BREATHING FILTER2Cleared 510(K)
- K925388LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER2Cleared 510(K)
- K931217BREATHING FILTER2Cleared 510(K)
- K930760MED-PLASTICS INTL., INC. BREATHING FILTER2Cleared 510(K)
- K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTER2Cleared 510(K)
- K920885VENTILATOR CIRCUITS2Cleared 510(K)
- K923661QUADRASORB FILTER2Cleared 510(K)
- K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER2Cleared 510(K)
- K912577BACTERIA FILTER2Cleared 510(K)
- K911427BREATHING FILTERS2Cleared 510(K)
- K911738MEDICAL ASSEMBLIES FILTER2Cleared 510(K)
- K911651ZEFON BATERIAL/VIRAL FILTER2Cleared 510(K)
- K904830BACTERIA FILTER2Cleared 510(K)
- K903056BACTTRAP2Cleared 510(K)
- K901816PRESSURE TUBING AND ACCESSORIES2Cleared 510(K)
- K901476MODIFIED ENTRAPPING FILTER2Cleared 510(K)
- K900990FILT-R-ALL BACTERIAL/VIRAL FILTER2Cleared 510(K)
- K896832FILT-R-ALL BACTERIAL FILTER2Cleared 510(K)
- K896116ENTRAPPING FILTER2Cleared 510(K)
- K895233BACTERIAL AND VIRAL FILTER2Cleared 510(K)
- K894978BACTERIAL FILTER2Cleared 510(K)
- K893030CHILD SIZE - FILTER FLEX (TM)2Cleared 510(K)
- K892230RCI VIRAL/BACTERIAL FILTER2Cleared 510(K)
- K892520BREATHING CIRCUIT BACTERIAL FILTERS2Cleared 510(K)
- K890035BACTERIA FILTER2Cleared 510(K)
- K890362OMNIFILTER MAIN FLOW BACTERIA FILTER2Cleared 510(K)
- K890346INTERTECH UNIVERSAL HYDROPHOBIC FILTER2Cleared 510(K)
- K884465SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)2Cleared 510(K)
- K883693RESUSCITATION BAG EXHALATION FILTER2Cleared 510(K)
- K880681MINI-FILTER, VIROBAC II2Cleared 510(K)
- K880958LIFEGUARD BACTERIAL AND VIRAL FILTER2Cleared 510(K)
- K871366SIEMENS MAIN FLOW BACTERIA FILTER2Cleared 510(K)
- K864103CURITY ANESTHESIA FILTER2Cleared 510(K)
- K862786MP-50T DISPOSABLE BREATHING CIRCUIT FILTER2Cleared 510(K)
- K862790MP-01X-I DISPOSABLE FILTER KIT2Cleared 510(K)
- K862789MP-01X DISPOSABLE BACTERIA FILTER KIT2Cleared 510(K)
- K862787MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER2Cleared 510(K)
- K862785MP-1204 DISPOSABLE BACTERIA FILTER2Cleared 510(K)
- K853577MEDIPART BACTERIA FILTER MP-26152Cleared 510(K)
- K851070RESP-BAC BACTERIA FILTER2Cleared 510(K)
- K850265AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE2Cleared 510(K)
- K850327PALL GAS LINE GUARDIAN FILTER2Cleared 510(K)
- K844491MEDIPART FILTER & TUBING MP-02X2Cleared 510(K)
- K844492MEDIPART BACTERIA FILTER MP-30X2Cleared 510(K)
- K842580ACCESSORY FOR ADULT VOL. VENTILATOR2Cleared 510(K)
- K841581UNIFILTER ANESTHESIA & RESPIRATORY FILT2Cleared 510(K)
- K841236FILTER-FLEX2Cleared 510(K)
- K840960PALL COALESCER2Cleared 510(K)
- K840205DRYDEN MINI BACTERIA FILTER2Cleared 510(K)
- K832935GASLINE FILTER, #EC-GLF SERIES2Cleared 510(K)
- K833269RESPIR GARD BACTERIA FILTER2Cleared 510(K)
- K833267RESPIR GARD-II OXYGARD HYDROGARD-SPIRO2Cleared 510(K)
- K833066DRYDEN MINI BACTERIA FILTER2Cleared 510(K)
- K831856BREATHING CIRCUIT BACTERIA FILTER2Cleared 510(K)
- K830618BREATHING FILTER2Cleared 510(K)
- K823257NON-REUSABLE UNIVERSAL NEBULIZER FILTE2Cleared 510(K)
- K821310ESPREE' ANESTHESIA BACTERIAL FILTER2Cleared 510(K)
- K820576MAINFLOW BACTERIA FILTER2Cleared 510(K)
- K820577ANESTHESIA BACTERIA FILTER2Cleared 510(K)
- K812573SPIROMETER FILTER2Cleared 510(K)
- K812098MINI NICHOLES2Cleared 510(K)
- K812075NICHOLE'S 992Cleared 510(K)
- K811546NICHOLAS II, VIRAL-BACTERIAL FILTER2Cleared 510(K)
- K8029146-435 FILTER PAD, 5/PKG.2Cleared 510(K)
- K802763RESPIRGARD2Cleared 510(K)
- K801804ANESTHESIA BACTERIA FILTER2Cleared 510(K)
- K801803MAINFLOW BACTERIA FILTER2Cleared 510(K)
- K792097DRYDEN BACTERIA FILTER2Cleared 510(K)
- K791773VENTILATOR TUBE WITH FILTER2Cleared 510(K)
- K791307UNIPOR BREATHING CIRCUIT FILTER2Cleared 510(K)
- K790896TWO-WAY ANESTHESIA FILTER2Cleared 510(K)
- K781696COPPER-TRAP2Cleared 510(K)
- K780535HUMIDIFIER FILTER2Cleared 510(K)
- K772047RESPIRATORY KIT2Cleared 510(K)
- K770392MUFFLER, AIR PUMP2Cleared 510(K)
- K770375FILTER, AIR, CUTTER MAINLINE2Cleared 510(K)
- K770376FILTER, NEBULIZER, CUTTER2Cleared 510(K)
- K770136DISPOSABLE BACTERIA FILTER2Cleared 510(K)
- K7606113M BRAND ANESTHESIA FILTER,#31102Cleared 510(K)
- K760567BACTERIA FILTER2Cleared 510(K)
- K760041FILTER, RESPIRATORY (U-MID)2Cleared 510(K)
- K760081FILTER, BACTERIA (#2290)2Cleared 510(K)
- MAJCatheter, Percutaneous, Intraspinal, Short Term2Product Code
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)1Product Code
- LEYSet, Oral Administration2Product Code
- NIHDisinfectant, Subsystem, Water Purification2Product Code
- NIIDisinfectant, Dialysate Delivery System2Product Code
- FLJUnit, Airflow, Laminar2Product Code
- FRTUnit, Isolation, Surgical2Product Code
- FYDApparatus, Exhaust, Surgical2Product Code
- ORCAir Filter Portable Apparatus2Product Code
- QGIAir-Handling Apparatus Accessory1Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
ENGSTROM HMEF 1000
- Page Type
- Cleared 510(K)
- 510(k) Number
- K964204
- 510(k) Type
- Traditional
- Applicant
- DATEX ENGSTROM AB
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/13/1996
- Days to Decision
- 76 days
- Submission Type
- Statement