Cleared Traditional

K913031 - K-STIM

K913031 is an FDA 510(k) clearance for K-STIM, manufactured by Katecho, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K913031 · Katecho, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
205d
Days
Class 2
Risk

K913031 is an FDA 510(k) clearance for the K-STIM. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 205 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Katecho, Inc. devices

FDA 510(k) Submission Details - K913031

510(k) Number K913031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date January 30, 1992
Days to Decision 205 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 148d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 301
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K913031.
REUSABLE FINGER CLIP RECORDING ELECTRODE
K925706 · Chalgren Enterprises, Inc. · Feb 1993
BIO-DETEK TRACERITE EEG ELECTRODE
K920264 · Bio-Detek, Inc. · Jun 1992
ELECTRODE
K912643 · Skylark Device Co., Ltd. · Feb 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · Labeltape Meditect, Inc. · Jan 1992
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
3M 6830 ELECTRODE
K905539 · 3M Healthcare · May 1991