Cleared Traditional

K242326 - Wave Electrode (AE02-60)

Also marketed or referenced as:
Wave Electrode (AE02-50)

K242326 is an FDA 510(k) clearance for Wave Electrode (AE02-60), manufactured by Bionit Labs Srl. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K242326 · Bionit Labs Srl · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
149d
Days
Class 2
Risk

K242326 is an FDA 510(k) clearance for the Wave Electrode (AE02-60). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bionit Labs Srl (Soleto, IT). The FDA issued a Cleared decision on January 2, 2025 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Bionit Labs Srl devices

FDA 510(k) Submission Details - K242326

510(k) Number K242326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2024
Decision Date January 02, 2025
Days to Decision 149 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
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 201
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