Friday FDA Follow-up: Tasso+TM Lancet Earns 510(k) Class II Clearance

Tasso+ device retrieved from:


Tasso, a Seattle based healthcare technology company, had just announced that the U.S. Food and Drug Administration (FDA) has granted them 510(k) clearance for their Tasso+TM lancet as a class II device. A lancet is typically a small needle with a plastic or rubber coating that fits into the top of a lancing device. These devices are used to draw blood that can then be applied to a glucose strip. Many lancets come as a component of a blood glucose monitoring kit and can be adjusted for injection depth.

Although lancets have been around for some time, the Tasso+TM lancet is the first single-use, patient-centric blood collection product to receive this clearance. According to Tasso, these lancets are intended to puncture the skin to obtain drops of capillary blood samples. It is projected that the Tasso+TM lancet will be available for purchase across the country starting in Q4 of this year.

In the past, several factors were limiting the U.S. lancet market growth. One of the limiting factors in the past was the reusability of the lancets. Previously the FDA announced that the responsibility of the reusability of single-use devices relies solely on the users. Despite these warnings, patients continued to reuse lancets because of the convenience and financial savings. Although this device does not directly eliminate this problem, Tasso mentions that their device will improve patient care by providing tests to patients quickly and conveniently.

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