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
| Country | Makers |
|---|---|
| United States | 15 |
| China | 7 |
| Taiwan | 6 |
| Mexico | 5 |
| United Kingdom | 2 |
| Finland | 2 |
| Denmark | 1 |
| Germany | 1 |
| Norway | 1 |
| Malaysia | 1 |
| Estonia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vortran Medical Technology 1, Inc. | Sacramento, CA, United States | Manufacturer | 3 | September 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bio-Med Devices, Inc. | Guilford, CT, United States | Manufacturer | 2 | June 5, 1987 | 0 | 0 | 0 | api.fda.gov |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Contract manufacturer, Manufacturer | 2 | August 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer, Specification developer | 2 | May 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 2 | May 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | January 9, 1990 | 0 | 0 | 0 | api.fda.gov |
| Ambu A/S | Ballerup Hovedstaden, Denmark | Specification developer | 1 | July 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | June 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| DRW Medical | Aston, PA, United States | Manufacturer | 1 | February 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 1 | November 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 1 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | December 17, 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 | 1 | December 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 1 | November 30, 2000 | 0 | 0 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | November 21, 1994 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | April 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | August 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Manufacturer, Repackager or relabeler | 1 | February 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Contract manufacturer, Manufacturer | 1 | July 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer | 1 | July 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 1 | July 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| AMBU Limited | XIANG YU F.T.Z., XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axcesor LLC | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D R Burton Healthcare, LLC | Farmville, NC, United States | 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 | |
| Foremount Enterprise Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KB Components Finland Oy | Nurmijarvi Etela-Karjala, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laerdal Medical (suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laerdal Medical A/S | STAVANGER Rogaland, Norway | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Platinum Focus Group Ltd. | London London, City of, United Kingdom | Exporter to the US, 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 | |
| RAUMEDIC Estonia AS | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.