Data / Medical devices / Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (BZE): 38 FDA-registered makers in 12 countries

38 establishments in 12 countries are registered with the FDA to make Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (product code BZE, Class 2, 21 CFR 868.5270). 17 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on June 18, 2026, and lists 4 recall events (3 Class I). FDA data exported November 3, 2026.

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Product code

BZE

Device class

2

Regulation

868.5270

Medical specialty

Anesthesiology

Makers by country

Makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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 June 18, 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.