Data / Medical devices / Monitor, Airway Pressure (Includes Gauge And/Or Alarm) / United States
FDA-registered makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm) in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (product code CAP). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Product code
- CAP
- Country
- United States
Makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm) in the United States
| 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 |
| 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 |
| DRW Medical | Aston, PA, United States | Manufacturer | 1 | February 9, 2018 | 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 |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 1 | November 30, 2000 | 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 |
| 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, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer | 1 | July 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Axcesor LLC | Menomonee Falls, WI, United States | 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 | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.