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Data / Medical devices / Valve, Non-Rebreathing / United States

FDA-registered makers of Valve, Non-Rebreathing in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Valve, Non-Rebreathing (product code CBP). 14 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device
Valve, Non-Rebreathing
Product code
CBP
Country
United States

Makers of Valve, Non-Rebreathing in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer3August 24, 1998000api.fda.gov
Spiracle TechnologyLos Alamitos, CA, United StatesManufacturer, Specification developer3November 17, 2017000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer2April 22, 2003000api.fda.gov
Tender CorporationLittleton, NH, United StatesRepackager or relabeler, Specification developer2December 1, 2011000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer1March 14, 2001000api.fda.gov
Dynarex Corp.Middletown, NY, United StatesSpecification developer1December 22, 2005010api.fda.gov
Fte Dynamics, LLCChino Hills, CA, United StatesSpecification developer1March 23, 2015000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1October 7, 1988000api.fda.gov
Iilabco LLCBrea, CA, United StatesSpecification developer1March 23, 2015000api.fda.gov
Inkwell Global MarketingManalapan, NJ, United StatesSpecification developer1November 17, 2017000api.fda.gov
MedSource Labs, LLCChanhassen, MN, United StatesComplaint file establishment, Specification developer1August 26, 2008000api.fda.gov
Sechrist Industries, Inc.Anaheim, CA, United StatesManufacturer1December 13, 1988000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1March 6, 1987000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer1February 3, 1992000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.