Cleared Traditional

K090067 - BACTRACK SELECT BREATHALYZER, MODEL S80

K090067 is an FDA 510(k) clearance for BACTRACK SELECT BREATHALYZER, manufactured by Khn Solutions, LLC. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K090067 · Khn Solutions, LLC · Toxicology device
Download Printable Device Report (PDF)
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Mar 2009
Decision
74d
Days
Class 1
Risk

K090067 is an FDA 510(k) clearance for the BACTRACK SELECT BREATHALYZER, MODEL S80. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Khn Solutions, LLC (Deer Field, US). The FDA issued a Cleared decision on March 24, 2009 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Khn Solutions, LLC devices

FDA 510(k) Submission Details - K090067

510(k) Number K090067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2009
Decision Date March 24, 2009
Days to Decision 74 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
13d faster than avg
Panel avg: 87d · This submission: 74d
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 9
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K090067.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
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POCKET BREATHALYZER. CONNECTABLES
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K052804 · Omega Point Systems, LLC · Dec 2005