Atlas FDA

CAH

202 FDA 510(k) clearances · Product code

88 daysmedian time to decision
281 days90th percentile
202clearances measured

FDA profile

Official device name
Filter, Bacterial, Breathing-Circuit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5260
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 56 · 2022: 67 · 2023: 40 · 2024: 51 · 2025: 79 · 2026: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (K252643)Teleflex Medical Sdn. Bhd.2026-05-15
Ambu® Virobac II® Exhalation Filter (K251583)Ambu A/S2026-04-30
Besmed Bacterial Filter and HMEF (K241339)Besmed Health Business Corp2024-11-14
Breathing circuit bacterial/viral filter (K222917)Shaoxing Haitech Medical Products Co., Ltd.2024-02-15
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (K230483)Passy-Muir, Inc.2023-09-16
TNI Clear-Guard™ 3 angled breathing filter (1545020) (K223258)Intersurgical , Ltd.2023-06-15
Filter and HME/Filter (K221472)Ningbo Huakun Medical Equipment Co., Ltd.2023-02-08
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (K221836)Drägerwerk AG & Co. KGaA2022-12-07
EasyOne Filter (K221250)Ndd Medizintechnik AG2022-11-22
GGM Breathing Circuit Bacterial Filter (K210352)Great Group Medical Co, Ltd.2022-03-27
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (K211286)Pall Corporation2021-11-16
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter (K202459)Pharma System AB2021-09-26
HepaShield Bacterial Viral Breathing System Filter (K191909)Flexicare Medical Limited.2020-03-23
Altera Filter and HME/Filter (K192713)Meditera Tibbi Malzeme San VE Tic AS2020-03-16
Servo Guard (K182862)Maquet Critical Care AB2019-10-21
SafeBreath Filter Mouthpiece (K190022)MD Diagnostics Limited2019-09-25
ThermoShield HME Filter (K163300)Flexicare Medical Limited.2017-03-22
Breathing circuit bacterial/viral filter (K151498)Zhejiang Haisheng Medical Device Co., Ltd.2015-12-18
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF (K141087)Intersurgical Incorporated2015-02-12
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER (K132709)Vr Medical2014-07-30
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER (K132679)Galemed Corp.2014-04-18
EXCELERON BACTERIAL FILTERS (K131626)Exceleron Medical2014-02-26
RT016 INSPIRATORY FILTER (K133666)Fisher & Paykel Healthcare, Ltd.2014-02-05
HYRDROMAX HMEF (K130664)A-M Systems2013-06-21
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (K121382)Westmed, Inc.2012-12-06
FLO-GUARD BREATHING FILTER (K121026)Intersurgical, Inc.2012-11-02
HUMID-VENT HEPA (K112958)Teleflex Medical2012-09-21
MEDISIZE RED AND MEDISIZE BLUE (K110246)Qserve America, Inc.2011-11-04
MICROGARD II (K111408)Carefusion Germany 234 GmbH2011-10-17
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 (K102483)Sunset Healthcare Solutions, LLC2011-09-13
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER (K092451)Intersurgical, Inc.2010-10-29
FIL 1520 (K101629)Glenn Medical Systems, Inc.2010-07-09
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER (K092409)Intersurgical, Inc.2010-03-10
BACT-TRAP HEPA MIDI (K093426)Pharma Systems AB2010-02-22
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER (K091363)Ag Industries2010-02-04
FLEXICARE BREATHING FILTERS (K092218)Flexicare Medical, Ltd.2009-10-06
THERMOFLO HCH, THERMOFLO FILTER (K090738)Arc Medical, Inc.2009-07-27
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER (K091185)Hsiner Co., Ltd.2009-07-24
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED (K081536)Medisize BV2009-01-23
FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (K072002)Draeger Medical AG & Co. KG2008-01-31
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER (K063526)A-M Systems, Inc.2007-06-29
FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) (K063125)Arc Medical, Inc.2007-04-13
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 (K061426)Porous Media Corp.2006-06-05
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 (K052087)Ag Industries2005-12-14
RT019 INSPIRATORY/EXPIRATORY FILTER (K050927)Fisher & Paykel Healthcare, Ltd.2005-08-01
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE (K050953)Air Safety, Ltd.2005-06-29
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER (K043120)Datex-Ohmeda, Inc.2005-03-01
ALL FLOW PULMONARY FUNCTION FILTER (K043148)Alliance Tech Medical, Inc.2004-12-13
KUNG SHIN, HMEF SK203 (K032878)Kung Shin Plastics Co., Ltd.2004-09-20
CLEAR-THERM MICRO HME, MODEL 1441 (K032322)Intersurgical, Inc.2004-05-13
AIR SAFETY HEPA AND NON-HEPA FILTERS (K033008)Air Safety, Ltd.2004-05-13
SERVO GUARD, MODEL 64 81 290 EH88E (K030071)Maquet, Inc.2004-04-26
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) (K032716)Portex , Ltd.2003-11-28
VENTLAB BACTERIAL FILTER, MODEL BF100 (K030271)Ventlab Corp.2003-07-07
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR (K030990)Datex-Ohmeda2003-06-25
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 (K024270)Intersurgical, Inc.2003-06-24
DATEX-OHMEDA HMEF 750 (K031653)Datex-Ohmeda2003-06-20
DATEX-OHMEDA HMEF MINI (K023641)Datex-Ohmeda2002-11-27
DATEX-OHMEDA HMEF 500 (K021265)Datex-Ohmeda2002-08-30
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM (K013093)Pall Medical2002-08-01
GARD FILTER, COMBIGARD FILTE / HME (K014281)Munktell Filter AB2002-06-26
BACSTOP FILTER,BACSTOP FILTER/HME (K014282)Munktell Filter AB2002-06-26
TERUMO GAS FILTER (K021020)Terumo Cardiovascular Systems Corp.2002-06-10
EMS ELECTROSTATIC FLITER AND HME COMBINATION (K013122)Engineered Medical Systems2002-04-19
EMS HEPA FILTER AND HME COMBINATIONS (K013089)Engineered Medical Systems2002-03-14
BREATHING CIRCUIT FILTER (K012958)Emergency Filtration Products, Inc.2002-02-22
FILTERFLO H (K011212)Arc Medical, Inc.2001-12-20
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 (K013200)Rennels Medical Corp.2001-12-14
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE (K012485)King Systems Corp.2001-10-09
END EXPIRATORY FILTER, MODEL RT020 (K002839)Fisher & Paykel Healthcare, Ltd.2001-10-04
AIRLIFE HEPA FILTER (K011132)Allegiance Healthcare Corp.2001-06-08
SLEEVED FILTER (K010040)King Systems Corp.2001-03-09
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (K002201)Sims Portex, Inc.2001-02-05
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K002506)Sims Portex, Inc.2000-12-14
VBMAX (K000654)A-M Systems, Inc.2000-11-14
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT (K990949)Intersurgical, Inc.1999-06-15
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 (K983610)Intersurgical, Inc.1999-04-30
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) (K983817)King Systems Corp.1999-03-01
LICHEN, BACTERIAL IN LINE BREATHING FILTER (K980662)Dhd Healthcare Corp.1998-09-14
CIRCUIT GUARD (K982239)Arc Medical, Inc.1998-08-14
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER (K982127)Porous Media Corp.1998-06-23
BREATHING CIRCUIT BACTERIAL FILTER (K973797)King Systems Corp.1998-03-12
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER (K973238)Bill Olson Corp.1998-03-11
72 HOUR USE TRACH CARE WITH MICROBAN (K974630)Ballard Medical Products1998-03-11
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) (K965016)Gibeck, Inc.1997-12-02
SPIROSAFE FILTER (K973314)Micro Direct, Inc.1997-11-21
FILTER (K970102)Promedic, Inc.1997-06-24
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) (K964382)Gibeck, Inc.1997-04-15
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER (K965020)Porous Media Corp.1997-03-14
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (K964979)Porous Media Corp.1997-03-11
9000 SERIES FILTER & FILTER/HME (K963053)Enternet Medical, Inc.1997-02-21
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (K962045)Mallinckrodt Medical1996-11-26
ENGSTROM HMEF 1000 (K964204)Datex Engstrom AB1996-11-13
RESPIRGARD II, SPIROGARD (K961838)Marquest Medical Products, Inc.1996-10-18
MERCURY MEDICAL CPR BAG EXHALATION FILTER (K954490)Mercury Medical1996-10-03
BACTERIA/VIRAL FILTER (K961914)Hudson Respiratory Care, Inc.1996-08-14
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT (K954828)Gibeck, Inc.1996-05-02
WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (K953687)Westmed Intl.1995-09-18
POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER (K952428)Porous Media Corp.1995-07-07
PFT FILTER (K952062)Intertech Resources, Inc.1995-06-08
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