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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 27
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K090067.
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714 · Skyfine Inc. Limited · Nov 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · Lifeloc Technologies, Inc. · Jul 2009
ALCO TUBE PLUS
K082080 · Alcotest Quebec · Apr 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801 · Khn Solutions, LLC · Mar 2009
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855 · Canada, Inc. · Dec 2008
KEY RING ALCOHOL BREATHALYZER
K082086 · The Ashley Collection, Inc. · Dec 2008
K090067 · BACTRACK SELECT BREATHALYZER, MODEL S80
Download PDF FDA Summary Khn Solutions, LLC