Data / Medical devices / System, Measurement, Blood-Pressure, Non-Invasive

System, Measurement, Blood-Pressure, Non-Invasive (DXN): 270 FDA-registered makers in 29 countries

270 establishments in 29 countries are registered with the FDA to make System, Measurement, Blood-Pressure, Non-Invasive (product code DXN, Class 2, 21 CFR 870.1130). 160 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 1,226 510(k) clearances under this code, the latest on October 1, 2026, and lists 23 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

DXN

Device class

2

Regulation

870.1130

Medical specialty

Cardiovascular

Makers by country

Makers of System, Measurement, Blood-Pressure, Non-Invasive

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 October 1, 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.