Assessing 510(k) Device Safety

The data was collected for a pilot study for a project that aims to assess how well the FDA's 510(k) pathway ensures the safety of medical devices. The project will use regulatory ancestry study methodologies to create lineage trees of medical devices cleared for the U.S. market under the 510(k) pathway, and will apply quantitative methods to assess the validity of numerous criticisms of the pathway. The data for the pilot study was obtained from publicly available FDA databases. The scope was limited to devices intended for use in removing thrombus from the neurovasculature of patients experiencing acute strokes. All devices bearing FDA-assigned product codes NRY and POL were included.