Data / Medical devices / Ventilator, Emergency, Powered (Resuscitator)

Ventilator, Emergency, Powered (Resuscitator) (BTL): 38 FDA-registered makers in 13 countries

38 establishments in 13 countries are registered with the FDA to make Ventilator, Emergency, Powered (Resuscitator) (product code BTL, Class 2, 21 CFR 868.5925). 25 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 100 510(k) clearances under this code, the latest on April 4, 2025, and lists 20 recall events (11 Class I). FDA data exported November 2, 2026.

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Product code

BTL

Device class

2

Regulation

868.5925

Medical specialty

Anesthesiology

Life sustaining or supporting

Yes

Makers by country

Makers of Ventilator, Emergency, Powered (Resuscitator)

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 April 4, 2025. 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.