Cleared Traditional

K221724 - Conductive Gel (FDA 510(k) Clearance)

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

K221724 · Tone-A-Matic International, Inc. · Neurology device
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Sep 2022
Decision
101d
Days
Class 2
Risk

K221724 is an FDA 510(k) clearance for the Conductive Gel. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Tone-A-Matic International, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 23, 2022 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Tone-A-Matic International, Inc. devices

Submission Details

510(k) Number K221724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2022
Decision Date September 23, 2022
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 68
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K221724.
Jmoon Conductive Gel
K243749 · Shenzhen Ulike Smart Electronics Co., Ltd. · Apr 2025
Avologi Gel Primer (Model: Av25)
K220735 · Premier North America, Inc. · Sep 2023
Conductive Gel
K222770 · Top-Rank Health Care Co., Ltd. · Dec 2022
EEG-acp
K212325 · Somnomedics GmbH · Jun 2022
AC Cream - Conductive paste
K212326 · Spes Medica Srl · Dec 2021
GT5 conductive & abrasive gel
K212787 · Wuhan Greentek Pty , Ltd. · Nov 2021