Cleared Traditional

K830992 - XCEL MODEL XE-1

K830992 is the FDA 510(k) clearance for XCEL MODEL XE-1 by Electrocaine Medical System. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K830992 · Electrocaine Medical System · Neurology device
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Aug 1983
Decision
136d
Days
Class 2
Risk

K830992 is an FDA 510(k) clearance for the XCEL MODEL XE-1. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Electrocaine Medical System (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 136 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 Electrocaine Medical System devices

Submission Details

510(k) Number K830992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date August 12, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 148d · This submission: 136d
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 49
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K830992.
SD PLUS PATIENT CAT.#78-8010
K840963 · Codman & Shurtleff, Inc. · Apr 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · Codman & Shurtleff, Inc. · Apr 1984
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982