Cleared Traditional

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) (K081855) - FDA 510(k) Clearance

Class I Toxicology device.

K081855 · Canada, Inc. · Toxicology device
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Dec 2008
Decision
172d
Days
Class 1
Risk

K081855 is an FDA 510(k) clearance for the IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS). Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Canada, Inc. (Atlanta, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 172 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.

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Submission Details

510(k) Number K081855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2008
Decision Date December 19, 2008
Days to Decision 172 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
85d slower than avg
Panel avg: 87d · This submission: 172d
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.