Cleared Traditional

K123470 - PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (FDA 510(k) Clearance)

Class I Toxicology device.

K123470 · Pas Systems International, Inc. · Toxicology device
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Apr 2013
Decision
167d
Days
Class 1
Risk

K123470 is an FDA 510(k) clearance for the PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Pas Systems International, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on April 29, 2013 after a review of 167 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3050 - 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 Pas Systems International, Inc. devices

Submission Details

510(k) Number K123470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date April 29, 2013
Days to Decision 167 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
80d slower than avg
Panel avg: 87d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DJZ Devices, Breath Trapping, Alcohol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3050
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.