Cleared Traditional

K921504 - REUSABLE DUAL DISC BAR ELECTRODES

K921504 is an FDA 510(k) clearance for REUSABLE DUAL DISC BAR ELECTRODES, manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K921504 · Chalgren Enterprises, Inc. · Neurology device
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Sep 1992
Decision
164d
Days
Class 2
Risk

K921504 is an FDA 510(k) clearance for the REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 - K921504

510(k) Number K921504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date September 11, 1992
Days to Decision 164 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
16d slower than avg
Panel avg: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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.