Data / Medical devices / Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK): 30 FDA-registered makers in 10 countries

30 establishments in 10 countries are registered with the FDA to make Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK, Class 2, 21 CFR 878.4850). 13 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on August 25, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

QRK

Device class

2

Regulation

878.4850

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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 August 25, 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.