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Data / Medical devices / United States / B & B Medical Technologies, Inc.

B & B Medical Technologies, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 7 510(k) clearances

B & B Medical Technologies, Inc. is registered with the FDA (registration 2938401) in Carlsbad, CA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 28, 2014. Registered through 2026. FDA data exported November 2, 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.

FDA registration number
2938401
Address
1954 Kellogg Ave Suite 100, Carlsbad, CA, United States, 92008
Owner or operator
B&B MEDICAL TECHNOLOGIES, INC. (9089880)
Roles
Complaint file establishment, Specification developer
First device listed
October 28, 1992
Registered through
2026
Brand names listed
Accutach Flow Sensor, B&B Bubbler, BODAI NEO2-SAFE, Baby Tape Plus, Bite Proof Bite Block, E.T. Tape II, ET Tape, Hope Nebulizer and more

Devices it lists

DeviceProduct codeClassRoleSource
Attachment, Breathing, Positive End Expiratory PressureBYE2Complaint file establishment, Specification developeraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Complaint file establishment, Specification developeraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Specification developeraccessdata.fda.gov
PneumotachometerJAX2Complaint file establishment, Specification developeraccessdata.fda.gov
Support, Breathing TubeJAY1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 28, 2014K133210B&B BUBBLERBYESubstantially EquivalentS & T Medical Technologies, Inc.accessdata.fda.gov
May 27, 1998K980407HOPE NEBULIZERCAFSubstantially EquivalentB&B Medical Technologies, Inc.accessdata.fda.gov
December 2, 1993K935171STABILTRACHCBHSubstantially EquivalentB&B Medical Technologies, Inc.accessdata.fda.gov
April 19, 1993K925386ADHESIVE E.T. TAPECBHUnknownB&B Medical Technologies, Inc.accessdata.fda.gov
July 31, 1991K912884E.T. TAPE IICBHSubstantially EquivalentB&B Medical Technologies, Inc.accessdata.fda.gov
October 20, 1987K873491BLOCK, BITE, INTUBATIONJAYSubstantially EquivalentB&B Medical Technologies, Inc.accessdata.fda.gov
January 14, 1977K770061VO RESPIRATORY PNEUMOTACHOGRAPHJAXSubstantially EquivalentResearch Development Corp.accessdata.fda.gov

Compare with other makers

Updated March 28, 2014. 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.