Cleared Special

Enobio Dx (Enobio Dx 8) (K261604) - FDA 510(k) Clearance

Also marketed or referenced as:
Enobio Dx (Enobio Dx 20) Enobio Dx (Enobio Dx 32)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261604 · Neuroelectrics Barcelona S.L.U. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
30d
Days
Class 2
Risk

K261604 is an FDA 510(k) clearance for the Enobio Dx (Enobio Dx 8). Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Neuroelectrics Barcelona S.L.U. (Barcelona, ES). The FDA issued a Cleared decision on June 13, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neuroelectrics Barcelona S.L.U. devices

Submission Details

510(k) Number K261604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2026
Decision Date June 13, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWQ Full-montage Standard Electroencephalograph

All 43
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K261604.
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