Data / Medical devices / Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (FJK): 38 FDA-registered makers in 14 countries

38 establishments in 14 countries are registered with the FDA to make Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK, Class 2, 21 CFR 876.5820). 20 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 77 510(k) clearances under this code, the latest on May 15, 2026, and lists 14 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code

FJK

Device class

2

Regulation

876.5820

Medical specialty

Gastroenterology, Urology

Life sustaining or supporting

Yes

Makers by country

Makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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 May 15, 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.