Cleared Traditional

K261805 - NEXT-Cue

K261805 is an FDA 510(k) clearance for NEXT-Cue, manufactured by Neuroxt, Inc.. The device is a Class 2 Neurology device with product code QWT cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K261805 · Neuroxt, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
129d
Days
Class 2
Risk

K261805 is an FDA 510(k) clearance for the NEXT-Cue. Classified as Prognostic Assessment Software Of Mild Cognitive Impairment (product code QWT), Class II - Special Controls.

Submitted by Neuroxt, Inc. (Seoul, KR). The FDA issued a Cleared decision on October 8, 2026 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1454 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261805

510(k) Number K261805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2026
Decision Date October 08, 2026
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 149d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QWT Device Classification - Class 2, Special Controls

Product Code QWT Prognostic Assessment Software Of Mild Cognitive Impairment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1454
Definition Prognostic Assessment Software Of Mild Cognitive Impairment. Prognostic Assessment Software Of Mild Cognitive Impairment Is A Prescription-only Device That Combines Information From Multiple Clinical Data Sources To Produce An Output Indicative Of The Likelihood That A Patient Diagnosed With Mild Cognitive Impairment Will Progress To More Severe Forms Of Cognitive Impairment, Or Will Develop Dementia, Such As Alzheimer’s Disease Dementia, Within A Specified Period Of Time. This Device Is Intended For Adjunctive Use And Not Intended As A Stand-alone Diagnostic Or Prognostic Too.
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 - QWT Prognostic Assessment Software Of Mild Cognitive Impairment

Devices cleared under the same product code (QWT) and FDA review panel - the closest regulatory comparables to K261805.
BrainSee
DEN220066 · Darmiyan, Inc. · Jan 2024
K261805 · NEXT-Cue
Download PDF FDA Summary Neuroxt, Inc.