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Data / Medical devices / Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP): 42 FDA-registered makers in 11 countries

42 establishments in 11 countries are registered with the FDA to make Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (product code CAP, Class 2, 21 CFR 868.2600). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 78 510(k) clearances under this code, the latest on November 13, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CAP
Device class
2
Regulation
868.2600
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States15
China7
Taiwan6
Mexico5
United Kingdom2
Finland2
Denmark1
Germany1
Norway1
Malaysia1
Estonia1

Makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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
Vortran Medical Technology 1, Inc.Sacramento, CA, United StatesManufacturer3September 18, 2019000api.fda.gov
Bio-Med Devices, Inc.Guilford, CT, United StatesManufacturer2June 5, 1987000api.fda.gov
Galemed Corp.WU-JIA Yilan, TaiwanContract manufacturer, Manufacturer2August 22, 2013000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer, Specification developer2May 1, 2019000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer2May 24, 2012000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2January 9, 1990000api.fda.gov
Ambu A/SBallerup Hovedstaden, DenmarkSpecification developer1July 22, 2004000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer1June 19, 2014000api.fda.gov
DRW MedicalAston, PA, United StatesManufacturer1February 9, 2018000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer1November 13, 2020000api.fda.gov
GaleMed (Xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer1November 18, 2010000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1December 17, 1996000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1December 17, 1996000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesSpecification developer1November 30, 2000000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1November 21, 1994000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer1April 25, 1996000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoManufacturer1August 22, 2002000api.fda.gov
Salaera, LLC d.b.a MaxtecSalt Lake City, UT, United StatesManufacturer, Repackager or relabeler1February 9, 2018000api.fda.gov
WESTMED de Mexico, S.A de C.V.Tecate Baja California, MexicoContract manufacturer, Manufacturer1July 22, 2004000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer1July 22, 2004000api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer, Manufacturer1July 22, 2004000api.fda.gov
AMBU LimitedXIANG YU F.T.Z., XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
D R Burton Healthcare, LLCFarmville, NC, United StatesManufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
KB Components Finland OyNurmijarvi Etela-Karjala, FinlandContract manufacturer0000api.fda.gov
Laerdal Medical (suzhou) Co., Ltd.215009 Suzhou Jiangsu Province, ChinaManufacturer0000api.fda.gov
Laerdal Medical A/SSTAVANGER Rogaland, NorwaySpecification developer0000api.fda.gov
Platinum Focus Group Ltd.London London, City of, United KingdomExporter to the US, Manufacturer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated November 13, 2020. 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.