Cleared Traditional

K910727 - EXCEL MODEL 2110

K910727 is an FDA 510(k) clearance for EXCEL MODEL 2110, manufactured by Excel Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K910727 · Excel Medical Systems, Inc. · Neurology device
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Jan 1992
Decision
331d
Days
Class 2
Risk

K910727 is an FDA 510(k) clearance for the EXCEL MODEL 2110. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Excel Medical Systems, Inc. (San Jose, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 331 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 Excel Medical Systems, Inc. devices

FDA 510(k) Submission Details - K910727

510(k) Number K910727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1991
Decision Date January 17, 1992
Days to Decision 331 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 148d · This submission: 331d
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 290
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K910727.
TEAM-MC II
K921828 · Henley Intl. · Sep 1992
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K915210 · Biomedical Life Systems, Inc. · May 1992
LOW BACK STRIP (OR) K-BACK
K912381 · Katecho, Inc. · Jan 1992
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc. · Dec 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
BIO TENS 601, 606 AND 608 (3000)
K912178 · Skylark Device Co., Ltd. · Oct 1991