Cleared Traditional

K931029 - DISPOSABLE CONCENTRIC NEEDLE ELECTRODE

K931029 is an FDA 510(k) clearance for DISPOSABLE CONCENTRIC NEEDLE ELECTRODE, manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 542-day FDA review.

K931029 · Chalgren Enterprises, Inc. · Neurology device
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Aug 1994
Decision
542d
Days
Class 2
Risk

K931029 is an FDA 510(k) clearance for the DISPOSABLE CONCENTRIC NEEDLE ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on August 25, 1994 after a review of 542 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K931029

510(k) Number K931029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date August 25, 1994
Days to Decision 542 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
394d slower than avg
Panel avg: 148d · This submission: 542d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 17
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K931029.
RE-USABLE MONOPOLAR NEEDLE
K953886 · Chalgren Enterprises, Inc. · Oct 1995
RE-USABLE CONCENTRIC NEEDLE
K953887 · Chalgren Enterprises, Inc. · Oct 1995
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
K932059 · Dantec Medical, Inc. · Oct 1994
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966 · Dantec Medical, Inc. · Mar 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K924521 · Chalgren Enterprises, Inc. · Feb 1993
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282 · Chalgren Enterprises, Inc. · Mar 1992