Cleared Traditional

K940812 - INSIGHT ELECTRONIC ALIGNMENT INDICATOR

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

K940812 · Andronic Devices, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K940812

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 149d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

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

All 32
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K940812.
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
K943929 · Greenleaf Medical Systems, Inc. · May 1995
LARGE MUSCLE STRENGTH GAUGE
K945630 · J-Tech, Inc. · May 1995
SAUNDERS ELECTRONIC INCLINOMETER
K943898 · The Saunders Group · Nov 1994
THE BTE VECTOR
K925225 · Baltimore Therapeutic Equipment Co. · Jun 1994
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
K933063 · Isotechnologies, Inc. · Jan 1994
BOOST, MICE, GAMESYS.
K924416 · Penny and Giles Biometrics , Ltd. · Jun 1993
K940812 · INSIGHT ELECTRONIC ALIGNMENT INDICATOR
Download PDF FDA Summary Andronic Devices, Ltd.