BCIwiki (bciwiki.com) — Universal Brain received an FDA 510(k) decision of Substantially Equivalent for UB ERP System on June 30, 2026, under submission number K253767. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Non-Normalizing Quantitative Electroencephalograph Software. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Event-related potentials are obtained by averaging EEG time-locked to stimuli; components such as P300 serve both clinical assessment and the classic paradigms behind noninvasive BCI spellers.