Cleared Traditional

K260064 - Neurora

K260064 is an FDA 510(k) clearance for Neurora, manufactured by Argus Cognitive, Inc.. The device is a Class 2 Neurology device with product code QPF cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K260064 · Argus Cognitive, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
266d
Days
Class 2
Risk

K260064 is an FDA 510(k) clearance for the Neurora. Classified as Pediatric Autism Spectrum Disorder Diagnosis Aid (product code QPF), Class II - Special Controls.

Submitted by Argus Cognitive, Inc. (Hanover, US). The FDA issued a Cleared decision on October 2, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1491 - 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.

View all Argus Cognitive, Inc. devices

FDA 510(k) Submission Details - K260064

510(k) Number K260064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2026
Decision Date October 02, 2026
Days to Decision 266 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
117d slower than avg
Panel avg: 149d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPF Device Classification - Class 2, Special Controls

Product Code QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1491
Definition A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients.
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.

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