Cleared Traditional

K812263 - KENZ-GELECT

K812263 is an FDA 510(k) clearance for KENZ-GELECT, manufactured by Suzuken Co., Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K812263 · Suzuken Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
81d
Days
Class 2
Risk

K812263 is an FDA 510(k) clearance for the KENZ-GELECT. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Suzuken Co., Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 81 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 Suzuken Co., Ltd. devices

FDA 510(k) Submission Details - K812263

510(k) Number K812263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date November 02, 1981
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
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 34
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K812263.
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
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · Abco Dealers, Inc. · Dec 1980
SPECTRA R PAD
K791013 · Parker Laboratories, Inc. · Sep 1979
MEDI-TRACE EEG CREME
K790818 · Graphic Controls Corp. · Jun 1979