2025-10-31 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears Persyst 15 EEG Review Software

Summary The FDA cleared Persyst Development's Persyst 15 EEG Review and Analysis Software on October 31, 2025, finding it substantially equivalent under submission number K252160 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings for clinician review.

Why it matters Automatic event detection is the layer where EEG reading is actually being automated, and each clearance in the category fixes the regulatory baseline that later detection algorithms will be measured against.

BCIwiki (bciwiki.com) — Persyst Development, LLC received an FDA 510(k) decision of Substantially Equivalent for its Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) on October 31, 2025, under submission number K252160. The submission followed the Traditional 510(k) clearance pathway.

FDA lists the product under the device classification name Automatic Event Detection Software For Full-Montage Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. That classification covers software that automatically marks events within full-montage electroencephalograph recordings.

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accessdata.fda.gov 2025-10-31

Persyst EEG United States

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