Cleared Traditional

K940812 - INSIGHT ELECTRONIC ALIGNMENT INDICATOR

K940812 is the FDA 510(k) clearance for INSIGHT ELECTRONIC ALIGNMENT INDICATOR by Andronic Devices, Ltd.. It is a Class 1 Neurology device (product code KQX) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

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.

Regulatory Peers - KQX Goniometer, Ac-powered

Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K940812.
SPINE MOTION ANALYZER WITH EMG
K920256 · Orthopedic Systems, Inc. · Aug 1992
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · Orthopedic Systems, Inc. · Jan 1990
HYPAL ADHESIVE TAPE
K832991 · Smith & Nephew, Inc. · Jan 1984
LAMOREUX-OSI ELECTROGONIOMETER
K831040 · Orthopedic Systems, Inc. · Jul 1983
ELECTRO-GONIOMETER
K812908 · Chattanooga Group, Inc. · Nov 1981