The 510(k) clearance is a market entry pathway for medical devices in the U.S., indicating that the device is substantially equivalent in safety and effectiveness to a legally marketed predicate. The clearance type is Special, and the advisory committee is Neurology. Pascall Systems, a U.S.-based company, developed PSU1 for quantitative analysis of EEG signals.
FDA Clears Pascall Systems' EEG Software Under 510(k)
Summary
Pascall Systems, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pascall Sensor Unit (PSU1) on August 19, 2026, with the agency finding the device substantially equivalent. The device is a Class II medical device under regulation number 882.1400, classification name Non-Normalizing Quantitative Electroencephalograph Software.
Why it matters
A regulatory step for BCI signal acquisition and decoding: 510(k) clearance means the quantitative EEG software PSU1 can be legally marketed in the U.S., which bears directly on commercializing EEG analysis tools.
Compiled by BCIwiki from public sources
Sources · 1
accessdata.fda.gov 2026-08-19