Cleared Traditional

K832067 - SHARE INT'L TDM

K832067 is an FDA 510(k) clearance for SHARE INT'L TDM, manufactured by Share Int'L. The device is a Class 2 Neurology device with product code HCJ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K832067 · Share Int'L · Neurology device
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Oct 1983
Decision
122d
Days
Class 2
Risk

K832067 is an FDA 510(k) clearance for the SHARE INT'L TDM. Classified as Device, Skin Potential Measurement (product code HCJ), Class II - Special Controls.

Submitted by Share Int'L (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1560 - 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.

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FDA 510(k) Submission Details - K832067

510(k) Number K832067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date October 27, 1983
Days to Decision 122 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCJ Device Classification - Class 2, Special Controls

Product Code HCJ Device, Skin Potential Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1560
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.