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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
CAH
Device class
2
Regulation
868.5260
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States23
Mexico16
China12
Taiwan9
United Kingdom7
Germany6
Malaysia3
Sweden3
Switzerland2
Ireland2
Canada2
Italy1
Finland1
New Zealand1
Turkey1
Estonia1
Costa Rica1
Sri Lanka1
South Korea1
Lithuania1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer15December 6, 2012000api.fda.gov
Intersurgical Ltd.Wokingham, Berkshire, United KingdomManufacturer, Specification developer10June 15, 2023000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer7May 13, 2004000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer7September 21, 2012011api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer6March 23, 2020000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer5November 26, 1996000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer5May 13, 2004000api.fda.gov
Mallinckrodt Dar S.r.l.MIRANDOLA Modena, ItalyManufacturer5November 26, 1996000api.fda.gov
Pentair Filtration SolutionsSaint Paul, MN, United StatesContract manufacturer, Manufacturer5June 5, 2006000api.fda.gov
Teleflex Medical Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer5September 21, 2012000api.fda.gov
A-M SystemsSequim, WA, United StatesManufacturer4November 22, 2022010api.fda.gov
WESTMED de Mexico, S.A de C.V.Tecate Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler4December 6, 2012000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer4December 6, 2012000api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer, Manufacturer4December 6, 2012000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandContract manufacturer, Manufacturer3March 1, 2005000api.fda.gov
Fisher & Paykel Healthcare, Ltd.EAST TAMAKI Auckland, New ZealandComplaint file establishment, Manufacturer3February 5, 2014000api.fda.gov
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer3November 16, 2021000api.fda.gov
King Systems Corporation.Noblesville, IN, United StatesManufacturer, Repackager or relabeler, Specification developer3March 1, 1999010api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.Tire Izmir, TurkeyManufacturer, Repackager or relabeler3December 7, 2022000api.fda.gov
Pall NewquayNewquay Cornwall, United KingdomManufacturer3November 16, 2021000api.fda.gov
Pall International, SarlFribourg, SwitzerlandExporter to the US, Specification developer3November 16, 2021000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanyManufacturer, Specification developer2December 7, 2022000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer, Specification developer2October 17, 2011000api.fda.gov
Pharma Systems ABLysekil Halland, SwedenManufacturer2September 26, 2021000api.fda.gov
Pharma Systems Eesti OURiidakula Hiiumaa, EstoniaManufacturer2September 26, 2021000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer, Repackager or relabeler2August 1, 2002000api.fda.gov
S & Mohr America, S.A. DE C.V.ESTADO DE MEXICO Ciudad de Mexico, MexicoManufacturer2March 16, 2020010api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer2December 18, 2015000api.fda.gov
Aerogen LtdDANGAN Galway(County), IrelandComplaint file establishment, Specification developer1July 7, 2003000api.fda.gov
AG Industries LLCFairburn, GA, United StatesManufacturer1February 4, 2010000api.fda.gov
Alliance Tech Medical, Inc.Granbury, TX, United StatesRepackager or relabeler, Specification developer1December 13, 2004010api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer1December 14, 2005000api.fda.gov
BESMED HEALTH BUSINESS CORP.-ChiayiDalin Township Chiayi(County), TaiwanManufacturer1November 14, 2024000api.fda.gov
BLS Systems, Ltd.OAKVILLE Ontario, CanadaRepackager or relabeler, Specification developer1October 3, 1996000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanManufacturer1November 14, 2024000api.fda.gov
CovidienCarlsbad, CA, United StatesSpecification developer1July 7, 1995000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer1November 30, 1994000api.fda.gov
Covidien- Galway(County), IrelandSpecification developer1July 7, 1995000api.fda.gov
Enchant Tek Co. Ltd.Dongshan Township, Yilan County Taipei, TaiwanContract manufacturer, Exporter to the US1December 13, 2004000api.fda.gov
Galemed Corp.WU-JIA Yilan, TaiwanManufacturer1April 18, 2014000api.fda.gov
Great Group Medical Co Ltd.Changhua County, TaiwanExporter to the US, Manufacturer1March 27, 2022000api.fda.gov
GVS Filter Technology De MexicoApodaca N.L Nuevo Leon, MexicoManufacturer1May 13, 2004000api.fda.gov
GVS Filter Technology UK LtdLancaster Lancashire, United KingdomManufacturer, Specification developer1May 13, 2004000api.fda.gov
GVS Technology (Suzhou) Co., LtdSuzhou Jiangsu, ChinaContract manufacturer, Manufacturer1May 13, 2004000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer1July 24, 2009000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer1July 24, 2009000api.fda.gov
IVEMSA S.A. de C.V DIVISION AG INDUSTRIESTijuana Baja California, MexicoManufacturer1December 14, 2005000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesManufacturer, Specification developer1April 19, 2002000api.fda.gov
Kung Shin Plastics Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer1September 20, 2004010api.fda.gov
KoKo PFT LTD.Waltham Abbey Essex, United KingdomManufacturer1October 21, 1993000api.fda.gov
Maquet Critical Care ABSOLNA Stockholm, SwedenManufacturer1April 26, 2004000api.fda.gov
MD Diagnostics LtdChatham Kent, United KingdomManufacturer1September 25, 2019000api.fda.gov
Medline Soluciones MedicasNuevo Laredo Tamaulipas, MexicoManufacturer, Repackager or relabeler1January 26, 1993000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer1October 3, 1996000api.fda.gov
NDD Medizintechnik AGZurich, SwitzerlandComplaint file establishment, Specification developer1November 22, 2022000api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltdCixi Zhejiang, ChinaManufacturer1February 8, 2023000api.fda.gov
Passy-Muir, Inc.Irvine, CA, United StatesManufacturer, Specification developer1September 16, 2023000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer, Manufacturer1April 5, 1985000api.fda.gov
Sdi Diagnostics, Inc.South Easton, MA, United StatesManufacturer1October 21, 1993000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer1February 15, 2024000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1April 15, 1997000api.fda.gov
Terumo Cardiovascular Costa Rica LLCZona Franca La Lima Cartago, Costa RicaManufacturer1June 10, 2002000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer, Manufacturer1June 24, 1997000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaManufacturer1July 30, 2014000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Aptyx - TrentonTRENTON Ontario, CanadaContract manufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Exceleron Medical, LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flodins Filter ABLysekil Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Fisher & Paykel Healthcare S.A.de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Flexicare Lanka (Pvt) LtdBandaragama Western, Sri LankaContract manufacturer0000api.fda.gov
Ganshorn Medizin Electronic GMBHBad Neustadt Bavaria, GermanyManufacturer0000api.fda.gov
GaleMed (Xiamen) Co., Ltd.XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
Haemotronic De Mexico S De RLREYNOSA Tamaulipas, MexicoContract manufacturer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer0000api.fda.gov
Intechrity IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Intersurgical Medical Apparatus (changzhou) Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Intersurgical Medical Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Kaesung Co., Ltd.Bucheon-Si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Mirion Technologies (capintec), IncFlorham Park, NJ, United StatesManufacturer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
Riensch & Held GMBH & Co. KGHamburg, GermanyContract manufacturer0000api.fda.gov
Saint-Gobain Performance Plastics L+S GMBHNeuhaus am Rennweg Thuringia, GermanyContract manufacturer0000api.fda.gov
Saykia CorporationChanghua County, TaiwanContract manufacturer0000api.fda.gov
Sunmed Ap, Ltd.ZHUHAI Guangdong, ChinaContract manufacturer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
UAB IntersurgicalPABRADE Svencionys, LithuaniaContract manufacturer0000api.fda.gov
Ventec Life Systems, Inc.Woodinville, WA, United StatesManufacturer0000api.fda.gov
Ventec Life Systems, Inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoContract manufacturer0000api.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.