2026-03-13 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears Zeto New Wave EEG System

Summary The FDA cleared Zeto's New Wave System on March 13, 2026, finding it substantially equivalent under submission number K260455 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. That category covers standard electroencephalograph hardware acquiring a complete montage of scalp channels.

Why it matters Full-montage clinical EEG is the reference standard against which lighter, faster headsets are judged, so this entry is worth keeping mainly as the date Zeto's New Wave entered that category and the pathway it took to get there.

BCIwiki (bciwiki.com) — Zeto, Inc. received an FDA 510(k) decision of Substantially Equivalent for New Wave System on March 13, 2026, under submission number K260455. The submission followed the Special 510(k) clearance pathway.

FDA lists the product under the device classification name Full-Montage Standard Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. That classification covers standard electroencephalograph hardware acquiring a complete montage of scalp channels.

Compiled by BCIwiki from public sources

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accessdata.fda.gov 2026-03-13

Zeto EEG Non-invasive BCI United States

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