Single Use Only Blood Lancet With an Integral Sharps Injury Prevention Feature

What Is This Device?

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.

What Is FDA Product Code FMK?

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature is FDA product code FMK, Class 2, 21 CFR 878.4850.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 29 clearances under this code; the FDA took a median of 68 days from receipt to decision on them. 6 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 17 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Environmental control (4), Process control (2) and Process design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.