Cleared Traditional

K192606 - SAC2 - Electrode Cream

K192606 is an FDA 510(k) clearance for SAC2 - Electrode Cream, manufactured by Spes Medica Srl. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K192606 · Spes Medica Srl · Neurology device
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Jan 2020
Decision
119d
Days
Class 2
Risk

K192606 is an FDA 510(k) clearance for the SAC2 - Electrode Cream. 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 January 17, 2020 after a review of 119 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 Spes Medica Srl devices

FDA 510(k) Submission Details - K192606

510(k) Number K192606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2019
Decision Date January 17, 2020
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K192606.
GT5 conductive & abrasive gel
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DR-HO'S Electro Therapy Conductive Gel
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Elefix V Paste for EEG & EMG
K191975 · Nihon Kohden Corporation · Feb 2020
Tech Dots - Adhesive and conductive gel
K190050 · Spes Medica Srl · Jul 2019
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994