DeviceClearance

Product code QRL— General, Plastic Surgery

Lancing device

Classification name
Multiple Use Blood Lancet For Single Patient Use Only
Device class
Class 2
Regulation
21 CFR 878.4850
Advisory panel
General, Plastic Surgery
Total cleared
27
First cleared
Most recent

FDA classification definition

“A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable 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 QRL under 21 CFR 878.4850, via openFDA

Market context for product code QRL

FDA has cleared 27 devices under product code QRL between 2022 and 2026, filed by 18 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 QRL

Adverse events under product code QRL

product code QRL
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QRL

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