Cleared Traditional

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225) - FDA 510(k) Clearance

Class I Toxicology device.

K102225 · Alcopro, Inc. · Toxicology device
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Apr 2011
Decision
240d
Days
Class 1
Risk

K102225 is an FDA 510(k) clearance for the ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Alcopro, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 6, 2011 after a review of 240 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 Alcopro, Inc. devices

Submission Details

510(k) Number K102225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date April 06, 2011
Days to Decision 240 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
153d slower than avg
Panel avg: 87d · This submission: 240d
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.