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Data / Medical devices / Humidifier, Respiratory Gas, (Direct Patient Interface) / United States

FDA-registered makers of Humidifier, Respiratory Gas, (Direct Patient Interface) in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT). 18 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Humidifier, Respiratory Gas, (Direct Patient Interface)
Product code
BTT
Country
United States

Makers of Humidifier, Respiratory Gas, (Direct Patient Interface) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer17July 2, 2025010api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer15August 10, 2023000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer8September 24, 20140101api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5March 31, 2008010api.fda.gov
CovidienCarlsbad, CA, United StatesSpecification developer4March 31, 2008000api.fda.gov
Medline Industries - Arlington HeightsArlington Heights, IL, United StatesManufacturer4August 1, 2014000api.fda.gov
Vapotherm Inc.Exeter, NH, United StatesManufacturer, Specification developer4April 13, 2026020api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer2September 21, 2017000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer1October 10, 1978000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1September 18, 2000000api.fda.gov
International Biomedical, Ltd.Austin, TX, United StatesManufacturer1April 3, 1987000api.fda.gov
Invent Medical CorporationCarlsbad, CA, United StatesManufacturer1June 14, 2024000api.fda.gov
Precision Medical, Inc.Northampton, PA, United StatesManufacturer1August 14, 1990000api.fda.gov
Pentair Filtration SolutionsSaint Paul, MN, United StatesManufacturer1August 8, 2006010api.fda.gov
Somnetics International, IncFridley, MN, United StatesSpecification developer1September 26, 2013000api.fda.gov
Salaera d.b.a Perma PureLakewood, NJ, United StatesManufacturer1November 12, 2020000api.fda.gov
Telesair, Inc.Irvine, CA, United StatesManufacturer1October 13, 2023000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer1April 3, 1987000api.fda.gov
Amsino Healthcare (USA) Inc.Vernon Hills, IL, United StatesManufacturer0000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hamilton Medical, Inc.Reno, NV, United StatesContract manufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer0000api.fda.gov
Oricare Inc.Quakertown, PA, United StatesSpecification developer0000api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer0000api.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.