Data / Medical devices / Stylet, Tracheal Tube

Stylet, Tracheal Tube (BSR): 92 FDA-registered makers in 18 countries

92 establishments in 18 countries are registered with the FDA to make Stylet, Tracheal Tube (product code BSR, Class 1, 21 CFR 868.5790). 5 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on August 11, 2017, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

BSR

Device class

1

Regulation

868.5790

Medical specialty

Anesthesiology

Makers by country

Makers of Stylet, Tracheal Tube

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 August 11, 2017. 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.