Cleared Traditional

K081855 - IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)

K081855 is an FDA 510(k) clearance for IMPAIR AWARE ALCOHOL LEVEL INDICATION S..., manufactured by Canada, Inc.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K081855 · Canada, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K081855

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 87d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

DJZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - DJZ Devices, Breath Trapping, Alcohol

All 27
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K081855.
ALCO TUBE PLUS
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K083801 · Khn Solutions, LLC · Mar 2009
KEY RING ALCOHOL BREATHALYZER
K082086 · The Ashley Collection, Inc. · Dec 2008
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848 · Q3 Innovations, LLC · Jul 2008
DRAEGER ALCOTEST 6510
K063443 · Drager Safety · Mar 2008
K081855 · IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
Download PDF FDA Summary Canada, Inc.