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Data / Medical devices / Chamber, Hyperbaric

Chamber, Hyperbaric (CBF): 16 FDA-registered makers in 7 countries

16 establishments in 7 countries are registered with the FDA to make Chamber, Hyperbaric (product code CBF, Class 2, 21 CFR 868.5470). 15 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 69 510(k) clearances under this code, the latest on November 21, 2024, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
CBF
Device class
2
Regulation
868.5470
Medical specialty
Anesthesiology
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States10
Australia1
India1
Austria1
Peru1
United Kingdom1
Argentina1

Makers of Chamber, Hyperbaric

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
Perry Baromedical CorporationRiviera Beach, FL, United StatesManufacturer10August 13, 2010000api.fda.gov
Pcci, IncAlexandria, VA, United StatesManufacturer6August 19, 2011000api.fda.gov
Hyperbaric Modular Systems, Inc.San Diego, CA, United StatesManufacturer4March 22, 2017000api.fda.gov
Sechrist Industries, Inc.Anaheim, CA, United StatesComplaint file establishment, Manufacturer4May 30, 2014010api.fda.gov
Fink Engineering Pty LtdLaverton North Victoria, AustraliaManufacturer2November 21, 2024000api.fda.gov
Tekna Manufacturing Pvt. Ltd.Chennai Tamil Nadu, IndiaManufacturer2December 6, 2000000api.fda.gov
Aha Hyperbarics GMBHVienna Wien, AustriaManufacturer1June 10, 2010000api.fda.gov
Hyperbaric For Life LLCWaddell, AZ, United StatesManufacturer1November 15, 2004000api.fda.gov
Hyperbaric S.A.C.Lima Lima(Region), PeruManufacturer1July 25, 2008000api.fda.gov
Hyperbaric Technologies, Inc.Amsterdam, NY, United StatesComplaint file establishment, Manufacturer1August 2, 2000000api.fda.gov
Sea-Long Medical Systems, LLCWaxahachie, TX, United StatesManufacturer1May 16, 2001000api.fda.gov
SOS Group GBR LtdBuckinghamshire, United KingdomManufacturer1July 22, 1991000api.fda.gov
Summit to Sea, LLC.Mound, MN, United StatesManufacturer1February 8, 2008000api.fda.gov
Typhoon Water WaresPocomoke City, MD, United StatesManufacturer1November 17, 2005000api.fda.gov
Us Hyperbaric Network LLCSunrise, FL, United StatesSpecification developer1May 4, 2023000api.fda.gov
Oxavita S.R.L.Buenos Aires, ArgentinaContract manufacturer0000api.fda.gov

Updated November 21, 2024. 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.