Cleared Traditional

K951485 - AVOXIMETER 4000 (FDA 510(k) Clearance)

Class I Toxicology device.

K951485 · A-Vox Systems, Inc. · Toxicology device
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Nov 1995
Decision
221d
Days
Class 1
Risk

K951485 is an FDA 510(k) clearance for the AVOXIMETER 4000. Classified as Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide (product code JKS), Class I - General Controls.

Submitted by A-Vox Systems, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 6, 1995 after a review of 221 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3220 - 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 A-Vox Systems, Inc. devices

Submission Details

510(k) Number K951485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date November 06, 1995
Days to Decision 221 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 87d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
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.