Cleared Traditional

INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812) - FDA 510(k) Clearance

Class I Neurology device.

K940812 · Andronic Devices, Ltd. · Neurology device
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Nov 1994
Decision
272d
Days
Class 1
Risk

K940812 is an FDA 510(k) clearance for the INSIGHT ELECTRONIC ALIGNMENT INDICATOR. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Andronic Devices, Ltd. (Richmond, B.C. Canada V6v 2j2, CA). The FDA issued a Cleared decision on November 21, 1994 after a review of 272 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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 Andronic Devices, Ltd. devices

Submission Details

510(k) Number K940812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date November 21, 1994
Days to Decision 272 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 148d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.