Cleared Traditional

K243289 - ADDNOX (BPSPM1) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243289 · Nu Eyne Co., Ltd. · Neurology device
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Jan 2025
Decision
90d
Days
Class 2
Risk

K243289 is an FDA 510(k) clearance for the ADDNOX (BPSPM1). Classified as Transcutaneous Nerve Stimulator For Adhd (product code QGL), Class II - Special Controls.

Submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 16, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5898 - 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 Nu Eyne Co., Ltd. devices

Submission Details

510(k) Number K243289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2024
Decision Date January 16, 2025
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QGL Transcutaneous Nerve Stimulator For Adhd
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5898
Definition A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead.
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.