Cleared Traditional

K923255 - Q-SD

K923255 is an FDA 510(k) clearance for Q-SD, manufactured by Quantitative Medicine, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K923255 · Quantitative Medicine, Inc. · Neurology device
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Oct 1992
Decision
95d
Days
Class 2
Risk

K923255 is an FDA 510(k) clearance for the Q-SD. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Quantitative Medicine, Inc. (Matgate, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 95 days - within the typical 510(k) review window.

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. 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 Quantitative Medicine, Inc. devices

FDA 510(k) Submission Details - K923255

510(k) Number K923255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date October 05, 1992
Days to Decision 95 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
53d faster than avg
Panel avg: 148d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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 289
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K923255.
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
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K-DISPERSE
K921679 · Katecho, Inc. · Oct 1992
TEAM-MC II
K921828 · Henley Intl. · Sep 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · Biomedical Life Systems, Inc. · May 1992
LOW BACK STRIP (OR) K-BACK
K912381 · Katecho, Inc. · Jan 1992