Cleared Traditional

K884611 - THE ORTHORANGER II ELECTRONIC GONIOMETER

K884611 is an FDA 510(k) clearance for THE ORTHORANGER II ELECTRONIC GONIOMETER, manufactured by Medical Instruments Technology, Inc.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K884611 · Medical Instruments Technology, Inc. · Neurology device
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Jan 1989
Decision
88d
Days
Class 1
Risk

K884611 is an FDA 510(k) clearance for the THE ORTHORANGER II ELECTRONIC GONIOMETER. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Medical Instruments Technology, Inc. (Alexandria, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Instruments Technology, Inc. devices

FDA 510(k) Submission Details - K884611

510(k) Number K884611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date January 31, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 10
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K884611.
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ELECTRO-GONIOMETER
K812908 · Chattanooga Group, Inc. · Nov 1981