QRK

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

Product code

QRK

Device name

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

Device class

Class 2

21 CFR

21 CFR 878.4850

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

8

Summaries archived here

8 (direct download)

510(k) clearances (all years, FDA)

17 (all years; only the last 3 years are listed here)

FDA classification definition

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-08-25.

8 summaries are archived here for direct download.