Cleared Traditional

K872045 - CONDUCTIVITY GEL

K872045 is an FDA 510(k) clearance for CONDUCTIVITY GEL, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K872045 · Futuremed Div. of Future Impex Corp. · Neurology device
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Jul 1987
Decision
49d
Days
Class 2
Risk

K872045 is an FDA 510(k) clearance for the CONDUCTIVITY GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on July 15, 1987 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K872045

510(k) Number K872045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date July 15, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
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 32
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K872045.
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990
TENS PREP
K893604 · Smith & Nephew United, Inc. · Nov 1989
CONDUCTIVITY GEL
K871913 · Futuremed Div. of Future Impex Corp. · Jul 1987
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
K852956 · Parker Laboratories, Inc. · Aug 1985