Cleared Traditional

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714) - FDA 510(k) Clearance

Class I Toxicology device.

K091714 · Skyfine Inc. Limited · Toxicology device
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Nov 2009
Decision
161d
Days
Class 1
Risk

K091714 is an FDA 510(k) clearance for the ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Skyfine Inc. Limited (Taipei County, TW). The FDA issued a Cleared decision on November 18, 2009 after a review of 161 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 Skyfine Inc. Limited devices

Submission Details

510(k) Number K091714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date November 18, 2009
Days to Decision 161 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
74d slower than avg
Panel avg: 87d · This submission: 161d
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.