Product Code: CAH FDA class 2 21 CFR 868.5260

Filter, Bacterial, Breathing-Circuit

Anesthesiology

The Breathing-Circuit Bacterial Filter is a device placed in-line with an anesthesia or ventilation breathing circuit to prevent the transmission of microorganisms between the patient and the circuit, protecting both the patient and equipment from contamination. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAH, regulated under 21 CFR 868.5260, within the Anesthesiology specialty. This device is eligible for third-party review.

510(k)s
202
FEI Numbers
141
Registration Numbers
141
Unique Applicants
126
Years Active
50

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Basic Information

Product Code
CAH
Device Class
FDA class 2
Regulation Number
868.5260
Medical Specialty
Anesthesiology
Review Panel
HO
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 202 510(k) clearances via K numbers.

K Number Device Name
K252643 Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
K251583 Ambu® Virobac II® Exhalation Filter
K241339 Besmed Bacterial Filter and HMEF
K222917 Breathing circuit bacterial/viral filter
K230483 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K223258 TNI Clear-Guard™ 3 angled breathing filter (1545020)
K221472 Filter and HME/Filter
K221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221250 EasyOne Filter
K210352 GGM Breathing Circuit Bacterial Filter
K211286 Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K202459 Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
K191909 HepaShield Bacterial Viral Breathing System Filter
K192713 Altera Filter and HME/Filter
K182862 Servo Guard
K190022 SafeBreath Filter Mouthpiece
K163300 ThermoShield HME Filter
K151498 Breathing circuit bacterial/viral filter
K141087 INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K132709 VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132679 AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
K131626 EXCELERON BACTERIAL FILTERS
K133666 RT016 INSPIRATORY FILTER
K130664 HYRDROMAX HMEF
K121382 WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121026 FLO-GUARD BREATHING FILTER
K112958 HUMID-VENT HEPA
K110246 MEDISIZE RED AND MEDISIZE BLUE
K111408 MICROGARD II
K102483 SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K092451 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K101629 FIL 1520
K092409 HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K093426 BACT-TRAP HEPA MIDI
K091363 COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
K092218 FLEXICARE BREATHING FILTERS
K090738 THERMOFLO HCH, THERMOFLO FILTER
K091185 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
K081536 MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K072002 FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
K063526 A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063125 FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
K061426 OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K052087 BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
K050927 RT019 INSPIRATORY/EXPIRATORY FILTER
K050953 AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
K043120 MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043148 ALL FLOW PULMONARY FUNCTION FILTER
K032878 KUNG SHIN, HMEF SK203
K033008 AIR SAFETY HEPA AND NON-HEPA FILTERS
K032322 CLEAR-THERM MICRO HME, MODEL 1441
K030071 SERVO GUARD, MODEL 64 81 290 EH88E
K032716 PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
K030271 VENTLAB BACTERIAL FILTER, MODEL BF100
K030990 DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K024270 CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
K031653 DATEX-OHMEDA HMEF 750
K023641 DATEX-OHMEDA HMEF MINI
K021265 DATEX-OHMEDA HMEF 500
K013093 PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
K014282 BACSTOP FILTER,BACSTOP FILTER/HME
K014281 GARD FILTER, COMBIGARD FILTE / HME
K021020 TERUMO GAS FILTER
K013122 EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013089 EMS HEPA FILTER AND HME COMBINATIONS
K012958 BREATHING CIRCUIT FILTER
K011212 FILTERFLO H
K013200 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
K012485 MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
K002839 END EXPIRATORY FILTER, MODEL RT020
K011132 AIRLIFE HEPA FILTER
K010040 SLEEVED FILTER
K002201 ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
K002506 BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K000654 VBMAX
K990949 CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
K983610 CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
K983817 BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
K980662 LICHEN, BACTERIAL IN LINE BREATHING FILTER
K982239 CIRCUIT GUARD
K982127 POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K973797 BREATHING CIRCUIT BACTERIAL FILTER
K974630 72 HOUR USE TRACH CARE WITH MICROBAN
K973238 ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
K965016 ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K973314 SPIROSAFE FILTER
K970102 FILTER
K964382 HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K965020 POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K964979 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K963053 9000 SERIES FILTER & FILTER/HME
K962045 ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K964204 ENGSTROM HMEF 1000
K961838 RESPIRGARD II, SPIROGARD
K954490 MERCURY MEDICAL CPR BAG EXHALATION FILTER
K961914 BACTERIA/VIRAL FILTER
K954828 ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K953687 WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER
K952428 POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
K952062 PFT FILTER
K951047 BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K952015 PRIMA FILTER
K951484 WESTMED BACTERIAL/VIRAL FILTER
K951410 DISPOSABLE PULMONARY FUNCTION FILTER
K915750 DISPOSABLE BACTERIAL BREATHNG FILTER
K945543 GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE
K944189 TRANSPARENT ANESTHESIA FILTER
K943874 PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS
K934132 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K944124 SPIROBAC ADAPTERS
K941676 STERIVENT AND STERIVENT S
K941536 BARRIERBAC AND BARRIERBAC S
K941381 HYGROBAC,S HYGROBOY AND HYGROBABY
K934272 SENSORMEDICS MICROGARD MICROBIAL FILTER
K934189 BARRIERFLEX-I, AND BARRIERFLES-II
K934509 PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER
K934475 KOKO FILTER II
K934540 BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER
K930816 HEPA FILTERED HME
K925462 BREATHING FILTERS 1942T/1941T/2014T
K931842 BREATHING FILTER
K925388 LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER
K931217 BREATHING FILTER
K930760 MED-PLASTICS INTL., INC. BREATHING FILTER
K925217 MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K920885 VENTILATOR CIRCUITS
K923661 QUADRASORB FILTER
K922492 SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER
K912577 BACTERIA FILTER
K911427 BREATHING FILTERS
K911738 MEDICAL ASSEMBLIES FILTER
K911651 ZEFON BATERIAL/VIRAL FILTER
K904830 BACTERIA FILTER
K903056 BACTTRAP
K901816 PRESSURE TUBING AND ACCESSORIES
K901476 MODIFIED ENTRAPPING FILTER
K900990 FILT-R-ALL BACTERIAL/VIRAL FILTER
K896832 FILT-R-ALL BACTERIAL FILTER
K896116 ENTRAPPING FILTER
K895233 BACTERIAL AND VIRAL FILTER
K894978 BACTERIAL FILTER
K893030 CHILD SIZE - FILTER FLEX (TM)
K892230 RCI VIRAL/BACTERIAL FILTER
K892520 BREATHING CIRCUIT BACTERIAL FILTERS
K890035 BACTERIA FILTER
K890362 OMNIFILTER MAIN FLOW BACTERIA FILTER
K890346 INTERTECH UNIVERSAL HYDROPHOBIC FILTER
K884465 SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
K883693 RESUSCITATION BAG EXHALATION FILTER
K880681 MINI-FILTER, VIROBAC II
K880958 LIFEGUARD BACTERIAL AND VIRAL FILTER
K871366 SIEMENS MAIN FLOW BACTERIA FILTER
K864103 CURITY ANESTHESIA FILTER
K862790 MP-01X-I DISPOSABLE FILTER KIT
K862789 MP-01X DISPOSABLE BACTERIA FILTER KIT
K862787 MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER
K862786 MP-50T DISPOSABLE BREATHING CIRCUIT FILTER
K862785 MP-1204 DISPOSABLE BACTERIA FILTER
K853577 MEDIPART BACTERIA FILTER MP-2615
K851070 RESP-BAC BACTERIA FILTER
K850265 AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
K850327 PALL GAS LINE GUARDIAN FILTER
K844492 MEDIPART BACTERIA FILTER MP-30X
K844491 MEDIPART FILTER & TUBING MP-02X
K842580 ACCESSORY FOR ADULT VOL. VENTILATOR
K841581 UNIFILTER ANESTHESIA & RESPIRATORY FILT
K841236 FILTER-FLEX
K840960 PALL COALESCER
K840205 DRYDEN MINI BACTERIA FILTER
K832935 GASLINE FILTER, #EC-GLF SERIES
K833269 RESPIR GARD BACTERIA FILTER
K833267 RESPIR GARD-II OXYGARD HYDROGARD-SPIRO
K833066 DRYDEN MINI BACTERIA FILTER
K831856 BREATHING CIRCUIT BACTERIA FILTER
K830618 BREATHING FILTER
K823257 NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K821310 ESPREE' ANESTHESIA BACTERIAL FILTER
K820577 ANESTHESIA BACTERIA FILTER
K820576 MAINFLOW BACTERIA FILTER
K812573 SPIROMETER FILTER
K812098 MINI NICHOLES
K812075 NICHOLE'S 99
K811546 NICHOLAS II, VIRAL-BACTERIAL FILTER
K802914 6-435 FILTER PAD, 5/PKG.
K802763 RESPIRGARD
K801804 ANESTHESIA BACTERIA FILTER
K801803 MAINFLOW BACTERIA FILTER
K792097 DRYDEN BACTERIA FILTER
K791773 VENTILATOR TUBE WITH FILTER
K791307 UNIPOR BREATHING CIRCUIT FILTER
K790896 TWO-WAY ANESTHESIA FILTER
K781696 COPPER-TRAP
K780535 HUMIDIFIER FILTER
K772047 RESPIRATORY KIT
K770392 MUFFLER, AIR PUMP
K770376 FILTER, NEBULIZER, CUTTER
K770375 FILTER, AIR, CUTTER MAINLINE
K770136 DISPOSABLE BACTERIA FILTER
K760611 3M BRAND ANESTHESIA FILTER,#3110
K760567 BACTERIA FILTER
K760041 FILTER, RESPIRATORY (U-MID)
K760081 FILTER, BACTERIA (#2290)

FEI Numbers

This FDA classification entry is associated with 141 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 141 registration numbers. Click on an entry to view related FDA registrations.