Cleared Traditional

K953219 - 22MM STAINLESS STEEL DISC ELECTRODE

K953219 is an FDA 510(k) clearance for 22MM STAINLESS STEEL DISC ELECTRODE, 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 88-day FDA review.

K953219 · Chalgren Enterprises, Inc. · Neurology device
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Oct 1995
Decision
88d
Days
Class 2
Risk

K953219 is an FDA 510(k) clearance for the 22MM STAINLESS STEEL DISC 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 October 6, 1995 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K953219

510(k) Number K953219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date October 06, 1995
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K953219.
EMG DISC RECORDING ELECTRODE WITH PIN
K952690 · Chalgren Enterprises, Inc. · Dec 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952908 · Chalgren Enterprises, Inc. · Dec 1995
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