Cleared Traditional

K011827 - ORTELIUS 800

K011827 is an FDA 510(k) clearance for ORTELIUS 800, manufactured by Orthoscan , Ltd.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K011827 · Orthoscan , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
77d
Days
Class 1
Risk

K011827 is an FDA 510(k) clearance for the ORTELIUS 800. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Orthoscan , Ltd. (Ra'Ananna, IL). The FDA issued a Cleared decision on August 28, 2001 after a review of 77 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 Orthoscan , Ltd. devices

FDA 510(k) Submission Details - K011827

510(k) Number K011827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date August 28, 2001
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
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
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