DeviceClearance

Product code QRK— General, Plastic Surgery

Disposable Blood Lancet

Classification name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device class
Class 2
Regulation
21 CFR 878.4850
Advisory panel
General, Plastic Surgery
Total cleared
17
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRK under 21 CFR 878.4850, via openFDA

Market context for product code QRK

FDA has cleared 17 devices under product code QRK between 2022 and 2026, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRK

Recent clearances under product code QRK

Data sourced from openFDA. This site is unofficial and independent of the FDA.