Cleared Traditional

K243289 - ADDNOX (BPSPM1)

K243289 is an FDA 510(k) clearance for ADDNOX (BPSPM1), manufactured by Nu Eyne Co., Ltd.. The device is a Class 2 Neurology device with product code QGL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K243289

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.

QGL Device Classification - Class 2, Special Controls

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.