Data / Medical devices / Sterilizer, Steam

Sterilizer, Steam (FLE): 36 FDA-registered makers in 15 countries

36 establishments in 15 countries are registered with the FDA to make Sterilizer, Steam (product code FLE, Class 2, 21 CFR 880.6880). 29 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 185 510(k) clearances under this code, the latest on June 24, 2026, and lists 17 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

FLE

Device class

2

Regulation

880.6880

Medical specialty

General Hospital

Makers by country

Makers of Sterilizer, Steam

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 24, 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.