Data / Medical devices / Filter, Bacterial, Breathing-Circuit
Filter, Bacterial, Breathing-Circuit (CAH): 94 FDA-registered makers in 20 countries
94 establishments in 20 countries are registered with the FDA to make Filter, Bacterial, Breathing-Circuit (product code CAH, Class 2, 21 CFR 868.5260). 64 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 202 510(k) clearances under this code, the latest on May 15, 2026, and lists 16 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- CAH
- Device class
- 2
- Regulation
- 868.5260
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 23 |
| Mexico | 16 |
| China | 12 |
| Taiwan | 9 |
| United Kingdom | 7 |
| Germany | 6 |
| Malaysia | 3 |
| Sweden | 3 |
| Switzerland | 2 |
| Ireland | 2 |
| Canada | 2 |
| Italy | 1 |
| Finland | 1 |
| New Zealand | 1 |
| Turkey | 1 |
| Estonia | 1 |
| Costa Rica | 1 |
| Sri Lanka | 1 |
| South Korea | 1 |
| Lithuania | 1 |
Makers of Filter, Bacterial, Breathing-Circuit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 15 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Manufacturer, Specification developer | 10 | June 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 7 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 7 | September 21, 2012 | 0 | 1 | 1 | api.fda.gov |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 6 | March 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 5 | November 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 5 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Dar S.r.l. | MIRANDOLA Modena, Italy | Manufacturer | 5 | November 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Pentair Filtration Solutions | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 5 | June 5, 2006 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 5 | September 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| A-M Systems | Sequim, WA, United States | Manufacturer | 4 | November 22, 2022 | 0 | 1 | 0 | api.fda.gov |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 4 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer | 4 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 4 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Contract manufacturer, Manufacturer | 3 | March 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 3 | February 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Global Life Sciences Solutions USA LLC | Marlborough, MA, United States | Complaint file establishment, Specification developer | 3 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | March 1, 1999 | 0 | 1 | 0 | api.fda.gov |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Manufacturer, Repackager or relabeler | 3 | December 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Pall Newquay | Newquay Cornwall, United Kingdom | Manufacturer | 3 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pall International, Sarl | Fribourg, Switzerland | Exporter to the US, Specification developer | 3 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Manufacturer, Specification developer | 2 | December 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer, Specification developer | 2 | October 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Pharma Systems AB | Lysekil Halland, Sweden | Manufacturer | 2 | September 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pharma Systems Eesti OU | Riidakula Hiiumaa, Estonia | Manufacturer | 2 | September 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer, Repackager or relabeler | 2 | August 1, 2002 | 0 | 0 | 0 | api.fda.gov |
| S & Mohr America, S.A. DE C.V. | ESTADO DE MEXICO Ciudad de Mexico, Mexico | Manufacturer | 2 | March 16, 2020 | 0 | 1 | 0 | api.fda.gov |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Contract manufacturer, Manufacturer | 2 | December 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Aerogen Ltd | DANGAN Galway(County), Ireland | Complaint file establishment, Specification developer | 1 | July 7, 2003 | 0 | 0 | 0 | api.fda.gov |
| AG Industries LLC | Fairburn, GA, United States | Manufacturer | 1 | February 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Alliance Tech Medical, Inc. | Granbury, TX, United States | Repackager or relabeler, Specification developer | 1 | December 13, 2004 | 0 | 1 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 1 | December 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| BESMED HEALTH BUSINESS CORP.-Chiayi | Dalin Township Chiayi(County), Taiwan | Manufacturer | 1 | November 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| BLS Systems, Ltd. | OAKVILLE Ontario, Canada | Repackager or relabeler, Specification developer | 1 | October 3, 1996 | 0 | 0 | 0 | api.fda.gov |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Manufacturer | 1 | November 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Specification developer | 1 | July 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 1 | November 30, 1994 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Galway(County), Ireland | Specification developer | 1 | July 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| Enchant Tek Co. Ltd. | Dongshan Township, Yilan County Taipei, Taiwan | Contract manufacturer, Exporter to the US | 1 | December 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Manufacturer | 1 | April 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Great Group Medical Co Ltd. | Changhua County, Taiwan | Exporter to the US, Manufacturer | 1 | March 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| GVS Filter Technology De Mexico | Apodaca N.L Nuevo Leon, Mexico | Manufacturer | 1 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| GVS Filter Technology UK Ltd | Lancaster Lancashire, United Kingdom | Manufacturer, Specification developer | 1 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| GVS Technology (Suzhou) Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 1 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 1 | July 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 1 | July 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| IVEMSA S.A. de C.V DIVISION AG INDUSTRIES | Tijuana Baja California, Mexico | Manufacturer | 1 | December 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Manufacturer, Specification developer | 1 | April 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Kung Shin Plastics Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | September 20, 2004 | 0 | 1 | 0 | api.fda.gov |
| KoKo PFT LTD. | Waltham Abbey Essex, United Kingdom | Manufacturer | 1 | October 21, 1993 | 0 | 0 | 0 | api.fda.gov |
| Maquet Critical Care AB | SOLNA Stockholm, Sweden | Manufacturer | 1 | April 26, 2004 | 0 | 0 | 0 | api.fda.gov |
| MD Diagnostics Ltd | Chatham Kent, United Kingdom | Manufacturer | 1 | September 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer, Repackager or relabeler | 1 | January 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | October 3, 1996 | 0 | 0 | 0 | api.fda.gov |
| NDD Medizintechnik AG | Zurich, Switzerland | Complaint file establishment, Specification developer | 1 | November 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 1 | February 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Passy-Muir, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | September 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer, Manufacturer | 1 | April 5, 1985 | 0 | 0 | 0 | api.fda.gov |
| Sdi Diagnostics, Inc. | South Easton, MA, United States | Manufacturer | 1 | October 21, 1993 | 0 | 0 | 0 | api.fda.gov |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 1 | February 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | April 15, 1997 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Costa Rica LLC | Zona Franca La Lima Cartago, Costa Rica | Manufacturer | 1 | June 10, 2002 | 0 | 0 | 0 | api.fda.gov |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer, Manufacturer | 1 | June 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Manufacturer | 1 | July 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Trenton | TRENTON Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceleron Medical, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flodins Filter AB | Lysekil Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare S.A.de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Lanka (Pvt) Ltd | Bandaragama Western, Sri Lanka | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ganshorn Medizin Electronic GMBH | Bad Neustadt Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intechrity Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Apparatus (changzhou) Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaesung Co., Ltd. | Bucheon-Si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riensch & Held GMBH & Co. KG | Hamburg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saint-Gobain Performance Plastics L+S GMBH | Neuhaus am Rennweg Thuringia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saykia Corporation | Changhua County, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.