Cleared Traditional

K102225 - ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST

K102225 is an FDA 510(k) clearance for ALCO-BREATH TUBE, manufactured by Alcopro, Inc.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K102225 · Alcopro, Inc. · Toxicology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K102225

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.

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 17
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K102225.
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K063443 · Drager Safety · Mar 2008
REDLINE ALCOHOL BREATH TESTER
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