Cleared Traditional

Tech Dots - Adhesive and conductive gel (K190050) - FDA 510(k) Clearance

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

K190050 · Spes Medica Srl · Neurology device
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Jul 2019
Decision
190d
Days
Class 2
Risk

K190050 is an FDA 510(k) clearance for the Tech Dots - Adhesive and conductive gel. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on July 19, 2019 after a review of 190 days - an extended review cycle.

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 Spes Medica Srl devices

Submission Details

510(k) Number K190050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2019
Decision Date July 19, 2019
Days to Decision 190 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
42d slower than avg
Panel avg: 148d · This submission: 190d
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 13
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K190050.
DR-HO'S Electro Therapy Conductive Gel
K200402 · Guangzhou Xinbo Electronic Co., Ltd. · Nov 2020
Elefix V Paste for EEG & EMG
K191975 · Nihon Kohden Corporation · Feb 2020
SAC2 - Electrode Cream
K192606 · Spes Medica Srl · Jan 2020
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · Abco Dealers, Inc. · Dec 1980