Cleared Traditional

INNOFLUOR TOPIRAMATE CONTROL SET (K970517) - FDA 510(k) Clearance

Class I Toxicology device.

K970517 · Oxis Intl., Inc. · Toxicology device
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May 1997
Decision
90d
Days
Class 1
Risk

K970517 is an FDA 510(k) clearance for the INNOFLUOR TOPIRAMATE CONTROL SET. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxis Intl., Inc. devices

Submission Details

510(k) Number K970517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date May 12, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - LAS Drug Specific Control Materials

All 82
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