Filter, Bacterial, Breathing-Circuit
FDA product code CAH · Class II (moderate risk) · 21 CFR 868.5260 · Anesthesiology
202510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Intersurgical, Inc. 11
- Medipart Jerry Alexander 8
- Porous Media Corp. 6
- Mallinckrodt Medical 5
- Omnicon Medical Corp. 5
- Vital Signs, Inc. 5
- King Systems Corp. 5
- Datex-Ohmeda, Inc. 5
- Arc Medical, Inc. 4
- Marquest Medical Products, Inc. 4
- Fisher & Paykel Healthcare, Ltd. 3
- Gibeck, Inc. 3
- Dryden Corp. 3
- Pall Biomedical Products Co. 3
- Intertech Resources, Inc. 3
- Cutter Laboratories, Inc. 3
- Flexicare Medical Limited. 3
- A-M Systems, Inc. 3
- Inhalation Plastics 2
- K & G Healthcare Ind., Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerCAH · Traditional | Pall Corporation | 11/16/2021SE |
| K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME…CAH · Traditional | Pharma System AB | 09/26/2021SE |
| K191909 | HepaShield Bacterial Viral Breathing System FilterCAH · Traditional | Flexicare Medical Limited. | 03/23/2020SE |
| K192713 | Altera Filter and HME/FilterCAH · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 03/16/2020SE |
| K182862 | Servo GuardCAH · Traditional | Maquet Critical Care AB | 10/21/2019SE |
| K190022 | SafeBreath Filter MouthpieceCAH · Traditional | MD Diagnostics Limited | 09/25/2019SE |
| K163300 | ThermoShield HME FilterCAH · Traditional | Flexicare Medical Limited. | 03/22/2017SE |
| K151498 | Breathing circuit bacterial/viral filterCAH · Traditional | Zhejiang Haisheng Medical Device Co., Ltd. | 12/18/2015SE |
| K141087 | Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled HmefCAH · Traditional | Intersurgical Incorporated | 02/12/2015SE |
| K132709 | VR Medical Heat and Moisture Exchanger and FilterCAH · Traditional | Vr Medical | 07/30/2014SE |
| K132679 | Af Viral/Bacterial Filter, BF Viral/Bacterial FilterCAH · Traditional | Galemed Corp. | 04/18/2014SE |
| K131626 | Exceleron Bacterial FiltersCAH · Traditional | Exceleron Medical | 02/26/2014SE |
| K133666 | RT016 Inspiratory FilterCAH · Traditional | Fisher & Paykel Healthcare, Ltd. | 02/05/2014SE |
| K130664 | Hyrdromax HmefCAH · Traditional | A-M Systems | 06/21/2013SE |
| K121382 | Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]CAH · Traditional | Westmed, Inc. | 12/06/2012SE |
| K121026 | Flo-Guard Breathing FilterCAH · Traditional | Intersurgical, Inc. | 11/02/2012SE |
| K112958 | Humid-Vent HepaCAH · Traditional | Teleflex Medical | 09/21/2012SE |
| K110246 | Medisize Red and Medisize BlueCAH · Special | Qserve America, Inc. | 11/04/2011SE |
| K111408 | Microgard IICAH · Traditional | Carefusion Germany 234 GmbH | 10/17/2011SE |
| K102483 | Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104CAH · Traditional | Sunset Healthcare Solutions, LLC | 09/13/2011SE |
| K092451 | Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger…CAH · Traditional | Intersurgical, Inc. | 10/29/2010SE |
| K101629 | Fil 1520CAH · Traditional | Glenn Medical Systems, Inc. | 07/09/2010SE |
| K092409 | Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear…CAH · Traditional | Intersurgical, Inc. | 03/10/2010SE |
| K093426 | Bact-Trap Hepa MidiCAH · Traditional | Pharma Systems AB | 02/22/2010SE |
| K091363 | Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…CAH · Traditional | Ag Industries | 02/04/2010SE |
| K092218 | Flexicare Breathing FiltersCAH · Traditional | Flexicare Medical, Ltd. | 10/06/2009SE |
| K090738 | Thermoflo HCH, Thermoflo FilterCAH · Traditional | Arc Medical, Inc. | 07/27/2009SE |
| K091185 | 70530-BACTIAL/VIRAL Filter, 70531-HMEF, 70536-BACTERIAL/VIRAL FilterCAH · Traditional | Hsiner Co., Ltd. | 07/24/2009SE |
| K081536 | Medisize Blue, Medisize Green, Medisize RedCAH · Traditional | Medisize BV | 01/23/2009SE |
| K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55CAH · Traditional | Draeger Medical AG & Co. KG | 01/31/2008SE |
| K063526 | A-M Systems Viromax Viral and Bacterial FilterCAH · Traditional | A-M Systems, Inc. | 06/29/2007SE |
| K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme)CAH · Traditional | Arc Medical, Inc. | 04/13/2007SE |
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47CAH · Traditional | Porous Media Corp. | 06/05/2006SE |
| K052087 | Breathing Filter Bacterial/Viral, Model AG7178CAH · Traditional | Ag Industries | 12/14/2005SE |
| K050927 | RT019 Inspiratory/Expiratory FilterCAH · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/01/2005SE |
| K050953 | Air Safety Model 3000/06 Filter Hepa ReusableCAH · Traditional | Air Safety, Ltd. | 06/29/2005SE |
| K043120 | Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterCAH · Traditional | Datex-Ohmeda, Inc. | 03/01/2005SE |
| K043148 | All Flow Pulmonary Function FilterCAH · Traditional | Alliance Tech Medical, Inc. | 12/13/2004SE |
| K032878 | Kung Shin, Hmef SK203CAH · Traditional | Kung Shin Plastics Co., Ltd. | 09/20/2004SE |
| K033008 | Air Safety Hepa and Non-Hepa FiltersCAH · Traditional | Air Safety, Ltd. | 05/13/2004SE |
| K032322 | Clear-Therm Micro Hme, Model 1441CAH · Traditional | Intersurgical, Inc. | 05/13/2004SE |
| K030071 | Servo Guard, Model 64 81 290 EH88ECAH · Traditional | Maquet, Inc. | 04/26/2004SE |
| K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)CAH · Traditional | Portex , Ltd. | 11/28/2003SE |
| K030271 | Ventlab Bacterial Filter, Model BF100CAH · Traditional | Ventlab Corp. | 07/07/2003SE |
| K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorCAH · Traditional | Datex-Ohmeda | 06/25/2003SE |
| K024270 | Clear-Therm 3 Hmef, Clear-Therm 3 with Superset Catheter Mount,Clear-Therm with Flexible…CAH · Traditional | Intersurgical, Inc. | 06/24/2003SE |
| K031653 | Datex-Ohmeda Hmef 750CAH · Special | Datex-Ohmeda | 06/20/2003SE |
| K023641 | Datex-Ohmeda Hmef MiniCAH · Special | Datex-Ohmeda | 11/27/2002SE |
| K021265 | Datex-Ohmeda Hmef 500CAH · Traditional | Datex-Ohmeda | 08/30/2002SE |
| K013093 | Pall Ultipor Anesthesia Breathing SystemCAH · Traditional | Pall Medical | 08/01/2002SE |
| K014282 | Bacstop Filter,Bacstop Filter/HmeCAH · Traditional | Munktell Filter AB | 06/26/2002SE |
| K014281 | Gard Filter, Combigard Filte / HmeCAH · Traditional | Munktell Filter AB | 06/26/2002SE |
| K021020 | Terumo Gas FilterCAH · Traditional | Terumo Cardiovascular Systems Corp. | 06/10/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | Engineered Medical Systems | 04/19/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | Engineered Medical Systems | 03/14/2002SE |
| K012958 | Breathing Circuit FilterCAH · Traditional | Emergency Filtration Products, Inc. | 02/22/2002SE |
| K011212 | Filterflo HCAH · Traditional | Arc Medical, Inc. | 12/20/2001SE |
| K013200 | Renmed Contami-Shield Breathing Circuit Sleeve, Model 9999/01CAH · Traditional | Rennels Medical Corp. | 12/14/2001SE |
| K012485 | MS-140 All-Round Enhanced Performance Filter; MS-141 All-Round Enhanced Performance…CAH · Traditional | King Systems Corp. | 10/09/2001SE |
| K002839 | End Expiratory Filter, Model RT020CAH · Traditional | Fisher & Paykel Healthcare, Ltd. | 10/04/2001SE |
| K011132 | Airlife Hepa FilterCAH · Special | Allegiance Healthcare Corp. | 06/08/2001SE |
| K010040 | Sleeved FilterCAH · Traditional | King Systems Corp. | 03/09/2001SE |
| K002201 | Electrostatic Hydrophobic Breathing FilterCAH · Traditional | Sims Portex, Inc. | 02/05/2001SE |
| K002506 | Breathing Filter for Disposable Anesthesia Breathing CircuitCAH · Traditional | Sims Portex, Inc. | 12/14/2000SE |
| K000654 | VbmaxCAH · Traditional | A-M Systems, Inc. | 11/14/2000SE |
| K990949 | Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas…CAH · Traditional | Intersurgical, Inc. | 06/15/1999SE |
| K983610 | Clear-Guard Midi, Clear-Guard Midi W/Flextube, Clear-Therm Mini, Clear-Therm Mini…CAH · Traditional | Intersurgical, Inc. | 04/30/1999SE |
| K983817 | Breathing Circuit Bacterial Filter/Heat and Moisture Exchanger (Hme/F)CAH · Traditional | King Systems Corp. | 03/01/1999SE |
| K980662 | Lichen, Bacterial in Line Breathing FilterCAH · Traditional | Dhd Healthcare Corp. | 09/14/1998SE |
| K982239 | Circuit GuardCAH · Traditional | Arc Medical, Inc. | 08/14/1998SE |
| K982127 | Porous Media DEF25 Disposable Respiratory FilterCAH · Special | Porous Media Corp. | 06/23/1998SE |
| K973797 | Breathing Circuit Bacterial FilterCAH · Traditional | King Systems Corp. | 03/12/1998SE |
| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | Ballard Medical Products | 03/11/1998SE |
| K973238 | Zefon Adult Anesthesia Breathing Circuit with Filter, Zefon Pediatric Anesthesia…CAH · Traditional | Bill Olson Corp. | 03/11/1998SE |
| K965016 | Iso-Gard Filter ANGLED(18212)/ISO-GARD Filter STRAIGHT(19212)CAH · Traditional | Gibeck, Inc. | 12/02/1997SE |
| K973314 | Spirosafe FilterCAH · Traditional | Micro Direct, Inc. | 11/21/1997SE |
| K970102 | FilterCAH · Traditional | Promedic, Inc. | 06/24/1997SE |
| K964382 | Humid-Vent Filter Compact Angled (18402)/HUMID-VENT Filter Compact STRAIGHT(19402)CAH · Traditional | Gibeck, Inc. | 04/15/1997SE |
| K965020 | Porous Media DBF23 Reusable Respiratory FilterCAH · Traditional | Porous Media Corp. | 03/14/1997SE |
| K964979 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | Porous Media Corp. | 03/11/1997SE |
| K963053 | 9000 Series Filter & Filter/HmeCAH · Traditional | Enternet Medical, Inc. | 02/21/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | Mallinckrodt Medical | 11/26/1996SE |
| K964204 | Engstrom Hmef 1000CAH · Traditional | Datex Engstrom AB | 11/13/1996SE |
| K961838 | Respirgard II, SpirogardCAH · Traditional | Marquest Medical Products, Inc. | 10/18/1996SE |
| K954490 | Mercury Medical CPR Bag Exhalation FilterCAH · Traditional | Mercury Medical | 10/03/1996SE |
| K961914 | Bacteria/Viral FilterCAH · Traditional | Hudson Respiratory Care, Inc. | 08/14/1996SE |
| K954828 | Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/PortCAH · Traditional | Gibeck, Inc. | 05/02/1996SE |
| K953687 | Westmed Pediatric Bacterial/Viral FilterCAH · Traditional | Westmed Intl. | 09/18/1995SE |
| K952428 | Porous Media DBF23-R Reusable Respiratory FilterCAH · Traditional | Porous Media Corp. | 07/07/1995SE |
| K952062 | PFT FilterCAH · Traditional | Intertech Resources, Inc. | 06/08/1995SE |
| K951047 | Bacterial/Viral Filter Product Numbers 5100FILT, 5100THINM, 5100HEPACAH · Traditional | Vital Signs, Inc. | 06/02/1995SE |
| K952015 | Prima FilterCAH · Traditional | Prima, Inc. | 05/22/1995SE |
| K951484 | Westmed Bacterial/Viral FilterCAH · Traditional | Westmed Intl. | 04/24/1995SE |
| K951410 | Disposable Pulmonary Function FilterCAH · Traditional | Creative Biomedics, Inc. | 04/24/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | Hospitak, Inc. | 11/30/1994SE |
| K945543 | Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter…CAH · Traditional | Intersect Medical Products, Inc. | 11/29/1994SE |
| K944189 | Transparent Anesthesia FilterCAH · Traditional | Anetec, Inc. | 10/28/1994SE |
| K943874 | Precison Thermoplastic Components Gas Ampling Lines and ConnectorsCAH · Traditional | Precision Thermoplastic Components, Inc. | 10/28/1994SE |
| K934132 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | Porous Media Corp. | 10/04/1994SE |
| K944124 | Spirobac AdaptersCAH · Traditional | Mallinckrodt Medical | 09/08/1994SE |
| K941676 | Sterivent and Sterivent SCAH · Traditional | Mallinckrodt Medical | 05/20/1994SE |
| K941536 | Barrierbac and Barrierbac SCAH · Traditional | Mallinckrodt Medical | 04/19/1994SE |
| K941381 | Hygrobac,S Hygroboy and HygrobabyCAH · Traditional | Mallinckrodt Medical | 04/15/1994SE |
| K934272 | Sensormedics Microgard Microbial FilterCAH · Traditional | Sensor Medics Corp. | 11/24/1993SE |
| K934189 | Barrierflex-I, and Barrierfles-IiCAH · Traditional | Bird Life Design | 11/24/1993SE |
| K934509 | Pulmoguard Disposable Baterial/Viral FilterCAH · Traditional | Sdi Diagnostics, Inc. | 10/21/1993SE |
| K934475 | Koko Filter IICAH · Traditional | Pulmonary Data Services Inst., Inc. | 10/21/1993SE |
| K934540 | Barrierflex-Pf Pulmonary Function Testing FilterCAH · Traditional | Bird Life Design | 10/19/1993SE |
| K930816 | Hepa Filtered HmeCAH · Traditional | Intertech Resources, Inc. | 07/01/1993SE |
| K925462 | Breathing Filters 1942T/1941T/2014TCAH · Traditional | Intersurgical, Inc. | 05/21/1993SE |
| K931842 | Breathing FilterCAH · Traditional | Mag, Inc. | 05/19/1993SE |
| K925388 | Life Shield Healthcare Products Breathing FilterCAH · Traditional | Life Shield Healthcare Products, Inc. | 05/11/1993SE |
| K931217 | Breathing FilterCAH · Traditional | Teknor Medical Products, Inc. | 04/23/1993SE |
| K930760 | Med-Plastics Intl., Inc. Breathing FilterCAH · Traditional | Med-Plastics Intl., Inc. | 03/11/1993SE |
| K925217 | Meridian Medical Systems Breathing FilterCAH · Traditional | Merit Medical Systems, Inc. | 01/26/1993SE |
| K920885 | Ventilator CircuitsCAH · Traditional | Vital Signs, Inc. | 10/23/1992SE |
| K923661 | Quadrasorb FilterCAH · Traditional | Union Broach, Div. Moyco Industries, Inc. | 10/20/1992SE |
| K922492 | Specialty Packaging Prod Bacterial/Viral FilterCAH · Traditional | Specialty Packaging Producs, Inc. | 08/24/1992SE |
| K912577 | Bacteria FilterCAH · Traditional | Vital Signs, Inc. | 04/22/1992SE |
| K911427 | Breathing FiltersCAH · Traditional | Intersurgical, Inc. | 08/26/1991SE |
| K911738 | Medical Assemblies FilterCAH · Traditional | Medical Assemblies, Inc. | 07/11/1991SE |
| K911651 | Zefon Baterial/Viral FilterCAH · Traditional | Bill Olson Corp. | 05/30/1991SE |
| K904830 | Bacteria FilterCAH · Traditional | Vital Signs, Inc. | 04/10/1991SE |
| K903056 | BacttrapCAH · Traditional | Pharma Systems, Inc. | 11/05/1990SE |
| K901816 | Pressure Tubing and AccessoriesCAH · Traditional | Arbo Medical, Inc. | 07/12/1990SE |
| K901476 | Modified Entrapping FilterCAH · Traditional | Cadema Medical Products, Inc. | 05/01/1990SE |
| K900990 | Filt-R-All Bacterial/Viral FilterCAH · Traditional | Inhalation Plastics | 04/19/1990SE |
| K896832 | Filt-R-All Bacterial FilterCAH · Traditional | Inhalation Plastics | 01/22/1990SE |
| K896116 | Entrapping FilterCAH · Traditional | Cadema Medical Products, Inc. | 11/17/1989SE |
| K895233 | Bacterial and Viral FilterCAH · Traditional | F.L.W. Plastics, Inc. | 11/15/1989SE |
| K894978 | Bacterial FilterCAH · Traditional | Med-Tek Corp. | 11/02/1989SE |
| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | Life Design Systems, Inc. | 09/18/1989SE |
| K892230 | Rci Viral/Bacterial FilterCAH · Traditional | Respiratory Care, Inc. | 08/28/1989SE |
| K892520 | Breathing Circuit Bacterial FiltersCAH · Traditional | Arbo Medical, Inc. | 08/02/1989SE |
| K890035 | Bacteria FilterCAH · Traditional | Hudson Oxygen Therapy Sales Co. | 05/05/1989SE |
| K890362 | Omnifilter Main Flow Bacteria FilterCAH · Traditional | Puritan Bennett Corp. | 03/14/1989SE |
| K890346 | Intertech Universal Hydrophobic FilterCAH · Traditional | Intertech/Ohio | 03/01/1989SE |
| K884465 | Spirometrics Model 2141 Spiro-Filter(Tm)CAH · Traditional | Spirometrics, Inc. | 11/09/1988SE |
| K883693 | Resuscitation Bag Exhalation FilterCAH · Traditional | Intertech Resources, Inc. | 09/30/1988SE |
| K880681 | Mini-Filter, Virobac IICAH · Traditional | King Systems Corp. | 04/29/1988SE |
| K880958 | Lifeguard Bacterial and Viral FilterCAH · Traditional | Lifeguard Medical Products, Inc. | 04/27/1988SE |
| K871366 | Siemens Main Flow Bacteria FilterCAH · Traditional | Siemens Elema AB | 05/14/1987SE |
| K864103 | Curity Anesthesia FilterCAH · Traditional | The Kendal Co. | 01/28/1987SE |
| K862790 | MP-01X-I Disposable Filter KitCAH · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862789 | MP-01X Disposable Bacteria Filter KitCAH · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862787 | MP-2831 Disposable Conductive Breathing FilterCAH · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862786 | MP-50T Disposable Breathing Circuit FilterCAH · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862785 | MP-1204 Disposable Bacteria FilterCAH · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K853577 | Medipart Bacteria Filter MP-2615CAH · Traditional | Medipart Jerry Alexander | 10/30/1985SE |
| K851070 | Resp-Bac Bacteria FilterCAH · Traditional | Medicomp, Inc. | 06/14/1985SE |
| K850265 | American Twa Way Filter -Bacterial/Viral-RetentiveCAH · Traditional | American Pharmaseal Div. Ahsc | 04/05/1985SE |
| K850327 | Pall Gas Line Guardian FilterCAH · Traditional | Pall Biomedical Products Co. | 02/26/1985SE |
| K844492 | Medipart Bacteria Filter MP-30XCAH · Traditional | Medipart Jerry Alexander | 12/04/1984SE |
| K844491 | Medipart Filter & Tubing MP-02XCAH · Traditional | Medipart Jerry Alexander | 12/04/1984SE |
| K842580 | Accessory for Adult Vol. VentilatorCAH · Traditional | Infrasonics Corp. | 08/24/1984SE |
| K841581 | Unifilter Anesthesia & Respiratory FiltCAH · Traditional | Dupaco, Inc. | 04/30/1984SE |
| K841236 | Filter-FlexCAH · Traditional | Life Design Systems, Inc. | 04/05/1984SE |
| K840960 | Pall CoalescerCAH · Traditional | Pall Biomedical Products Co. | 03/16/1984SE |
| K840205 | Dryden Mini Bacteria FilterCAH · Traditional | Dryden Corp. | 02/04/1984SE |
| K832935 | Gasline Filter, #Ec-Glf SeriesCAH · Traditional | Gish Biomedical, Inc. | 11/22/1983SE |
| K833269 | Respir Gard Bacteria FilterCAH · Traditional | Marquest Medical Products, Inc. | 10/31/1983SE |
| K833267 | Respir Gard-Ii Oxygard Hydrogard-SpiroCAH · Traditional | Marquest Medical Products, Inc. | 10/28/1983SE |
| K833066 | Dryden Mini Bacteria FilterCAH · Traditional | Dryden Corp. | 10/28/1983SE |
| K831856 | Breathing Circuit Bacteria FilterCAH · Traditional | Vital Signs, Inc. | 09/26/1983SE |
| K830618 | Breathing FilterCAH · Traditional | Ohio Medical Products | 04/08/1983SE |
| K823257 | Non-Reusable Universal Nebulizer FilteCAH · Traditional | Ohio Medical Products | 12/09/1982SE |
| K821310 | Espree' Anesthesia Bacterial FilterCAH · Traditional | Esp Plastics, Inc. | 06/11/1982SE |
| K820577 | Anesthesia Bacteria FilterCAH · Traditional | Omnicon Medical Corp. | 03/18/1982SE |
| K820576 | Mainflow Bacteria FilterCAH · Traditional | Omnicon Medical Corp. | 03/18/1982SE |
| K812573 | Spirometer FilterCAH · Traditional | K & G Healthcare Ind., Inc. | 10/23/1981SE |
| K812098 | Mini NicholesCAH · Traditional | Healthcare Ind. | 08/18/1981SE |
| K812075 | Nichole's 99CAH · Traditional | Healthcare Ind. | 08/12/1981SE |
| K811546 | Nicholas II, Viral-Bacterial FilterCAH · Traditional | K & G Healthcare Ind., Inc. | 08/03/1981SE |
| K802914 | 6-435 Filter Pad, 5/PKG.CAH · Traditional | Lifecare Services, Inc. | 12/19/1980SE |
| K802763 | RespirgardCAH · Traditional | Marquest Medical Products, Inc. | 11/26/1980SE |
| K801804 | Anesthesia Bacteria FilterCAH · Traditional | Omnicon Medical Corp. | 08/13/1980SE |
| K801803 | Mainflow Bacteria FilterCAH · Traditional | Omnicon Medical Corp. | 08/13/1980SE |
| K792097 | Dryden Bacteria FilterCAH · Traditional | Dryden Corp. | 11/13/1979SE |
| K791773 | Ventilator Tube with FilterCAH · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 10/22/1979SE |
| K791307 | Unipor Breathing Circuit FilterCAH · Traditional | Pall Biomedical Products Co. | 08/03/1979SE |
| K790896 | Two-Way Anesthesia FilterCAH · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 06/05/1979SE |
| K781696 | Copper-TrapCAH · Traditional | Olympic Medical Corp. | 11/03/1978SE |
| K780535 | Humidifier FilterCAH · Traditional | Hudson Oxygen Therapy Sales Co. | 04/27/1978SE |
| K772047 | Respiratory KitCAH · Traditional | American Hospital Supply Corp. | 11/23/1977SE |
| K770392 | Muffler, Air PumpCAH · Traditional | Cutter Laboratories, Inc. | 03/07/1977SE |
| K770376 | Filter, Nebulizer, CutterCAH · Traditional | Cutter Laboratories, Inc. | 03/01/1977SE |
| K770375 | Filter, Air, Cutter MainlineCAH · Traditional | Cutter Laboratories, Inc. | 03/01/1977SE |
| K770136 | Disposable Bacteria FilterCAH · Traditional | Omnicon Medical Corp. | 02/14/1977SE |
| K760611 | 3M Brand Anesthesia FILTER,#3110CAH · Traditional | 3M Company | 09/21/1976SE |
| K760567 | Bacteria FilterCAH · Traditional | Foregger Air Products & Chem., Inc. | 09/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0449-2026 Class I | Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-2161-2025 Class I | SafeStar 60A Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2160-2025 Class I | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2159-2025 Class I | SafeStar 55 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2158-2025 Class I | SafeStar 90 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-1269-2025 Class II | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The… | Kung Shin Plastics Co. Ltd. | 01/09/2025Open, Classified |
| Z-1268-2025 Class II | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral…The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The… | Kung Shin Plastics Co. Ltd. | 01/09/2025Open, Classified |
| Z-3031-2024 Class II | Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2466-2023 Class II | PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filterSmiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the… | Smiths Medical ASD Inc. | 07/18/2023Open, Classified |
| Z-1160-2023 Class III | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm…Incorrect expiration date on product label. The manufacturing date was listed as the expiration date.… | S & Mohr America, S.A. de C.V. | 01/05/2023Open, Classified |
| Z-0077-2023 Class I | Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-0076-2023 Class I | Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-0075-2023 Class I | Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-0074-2023 Class I | Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-0073-2023 Class I | Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-0072-2023 Class I | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter…Incidents of device splitting or detaching during use | Teleflex LLC | 08/29/2022Open, Classified |
| Z-1211-2022 Class I | Drager SafeStar 55, Catalog No. MP01790Possible occlusion of filters due to manufacturing error. | Draeger Medical, Inc. | 05/16/2022Open, Classified |
| Z-1869-2021 Class II | HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for…The company was notified by their supplier of sterilization services for airway products in Italy of… | Covidien, LP | 04/29/2021Open, Classified |
| Z-1868-2021 Class II | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated…The company was notified by their supplier of sterilization services for airway products in Italy of… | Covidien, LP | 04/29/2021Open, Classified |
| Z-1867-2021 Class II | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product…The company was notified by their supplier of sterilization services for airway products in Italy of… | Covidien, LP | 04/29/2021Open, Classified |
| Z-1866-2021 Class II | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single…The company was notified by their supplier of sterilization services for airway products in Italy of… | Covidien, LP | 04/29/2021Open, Classified |
| Z-0321-2018 Class II | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z…Potential for leak test failures. | King Systems Corp. dba Ambu, Inc. | 03/15/2017Terminated |
| Z-0714-2020 Class II | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters…Patients have experienced a bad taste associated with the filters. | Alliance Tech Medical, Inc | 10/06/2014Completed |
| Z-2038-2014 Class II | PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use…Possible leak from the filter allowing a small of amount of air to be released from the junction between the… | Pall Corporation | 06/04/2014Terminated |
| Z-0812-2014 Class II | Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an…A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result… | Vital Signs Colorado Inc. | 12/26/2013Terminated |
| Z-1754-2010 | Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit"…CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component… | Continental Medical Labs,Inc | 04/16/2010Terminated |
| Z-0308-2012 | ViroMax viral/bacterial filter. The filter reduces the risk of infection due to…Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are… | A M Systems Inc | 03/31/2010Terminated |