Cleared Traditional

K922202 - K-STIM CLEAR

K922202 is the FDA 510(k) clearance for K-STIM CLEAR by Katecho, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K922202 · Katecho, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
371d
Days
Class 2
Risk

K922202 is an FDA 510(k) clearance for the K-STIM CLEAR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K922202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date May 17, 1993
Days to Decision 371 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 148d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 129
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K922202.
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · Chattanooga Group, Inc. · May 1994
HOME MICROCURRENT HMC
K935132 · Medical Devices, Inc. · Mar 1994
FLEXMATE
K934619 · Medical Devices, Inc. · Feb 1994
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686 · Biomedical Life Systems, Inc. · Mar 1993
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
TEAM-MC II
K921828 · Henley Intl. · Sep 1992