DeviceClearance

Product code FMK— General, Plastic Surgery

Safety Lancet

Classification name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class
Class 2
Regulation
21 CFR 878.4850
Advisory panel
General, Plastic Surgery
Total cleared
111
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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.”

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

Market context for product code FMK

FDA has cleared 111 devices under product code FMK between 1981 and 2026, filed by 67 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

last 15 years

Top applicants under product code FMK

Adverse events under product code FMK

product code FMK
Injury
133
Malfunction
1,278
Other
1
Total
1,412

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 FMK

1–100 of 111

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