Cleared Traditional

K904377 - ELECTROCONDUCTIVE MEDIA

K904377 is the FDA 510(k) clearance for ELECTROCONDUCTIVE MEDIA by Henley Intl.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K904377 · Henley Intl. · Neurology device
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Nov 1991
Decision
417d
Days
Class 2
Risk

K904377 is an FDA 510(k) clearance for the ELECTROCONDUCTIVE MEDIA. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on November 15, 1991 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Henley Intl. devices

Submission Details

510(k) Number K904377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date November 15, 1991
Days to Decision 417 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
269d slower than avg
Panel avg: 148d · This submission: 417d
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 24
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K904377.
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc. · Mar 1994
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990
TENS PREP
K893604 · Smith & Nephew United, Inc. · Nov 1989
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986