Data / Medical devices / Pump, Infusion

Pump, Infusion (FRN): 95 FDA-registered makers in 21 countries

95 establishments in 21 countries are registered with the FDA to make Pump, Infusion (product code FRN, Class 2, 21 CFR 880.5725). 58 of them have a 510(k) clearance or PMA approval on file and 17 have a recall event. The FDA has issued 849 510(k) clearances under this code, the latest on July 24, 2026, and lists 346 recall events (86 Class I). FDA data exported November 2, 2026.

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Product code

FRN

Device class

2

Regulation

880.5725

Medical specialty

General Hospital

Makers by country

Makers of Pump, Infusion

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 July 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.