Data / Medical devices / Nebulizer (Direct Patient Interface)

Nebulizer (Direct Patient Interface) (CAF): 133 FDA-registered makers in 18 countries

133 establishments in 18 countries are registered with the FDA to make Nebulizer (Direct Patient Interface) (product code CAF, Class 2, 21 CFR 868.5630). 101 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 509 510(k) clearances under this code, the latest on September 18, 2026, and lists 20 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code

CAF

Device class

2

Regulation

868.5630

Medical specialty

Anesthesiology

Makers by country

Makers of Nebulizer (Direct Patient Interface)

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 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.