Data / Medical devices / Tube, Tracheostomy (W/Wo Connector)

Tube, Tracheostomy (W/Wo Connector) (BTO): 29 FDA-registered makers in 7 countries

29 establishments in 7 countries are registered with the FDA to make Tube, Tracheostomy (W/Wo Connector) (product code BTO, Class 2, 21 CFR 868.5800). 24 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 129 510(k) clearances under this code, the latest on September 11, 2026, and lists 22 recall events (4 Class I). FDA data exported November 2, 2026.

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Product code

BTO

Device class

2

Regulation

868.5800

Medical specialty

Anesthesiology

Life sustaining or supporting

Yes

Makers by country

Makers of Tube, Tracheostomy (W/Wo Connector)

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.

Updated September 11, 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.