Cleared Traditional

K952690 - EMG DISC RECORDING ELECTRODE WITH PIN

K952690 is an FDA 510(k) clearance for EMG DISC RECORDING ELECTRODE WITH PIN, manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K952690 · Chalgren Enterprises, Inc. · Neurology device
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Dec 1995
Decision
177d
Days
Class 2
Risk

K952690 is an FDA 510(k) clearance for the EMG DISC RECORDING ELECTRODE WITH PIN. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 177 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K952690

510(k) Number K952690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date December 06, 1995
Days to Decision 177 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
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 207
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K952690.
EMG RECORDING RING ELECTRODE
K953356 · Chalgren Enterprises, Inc. · Jan 1996
EMG DISC RECORDING ELECTRODE
K953361 · Chalgren Enterprises, Inc. · Jan 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp. · Jan 1996
EMG DISC RECORDING ELECTRODE WITH PIN
K952908 · Chalgren Enterprises, Inc. · Dec 1995
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl. · Nov 1995
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K953219 · Chalgren Enterprises, Inc. · Oct 1995