Cleared Traditional

OPTAX SYSTEM (K020800) - FDA 510(k) Clearance

K020800 · Optax Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
90d
Days
-
Risk

K020800 is an FDA 510(k) clearance for the OPTAX SYSTEM. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Optax Systems, Inc. (Hopkonton, US). The FDA issued a Cleared decision on June 10, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Optax Systems, Inc. devices

Submission Details

510(k) Number K020800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date June 10, 2002
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -