Cleared Traditional

K083801 - BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70

K083801 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 87-day FDA review.

K083801 · Khn Solutions, LLC · Toxicology device
Download Printable Device Report (PDF)
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Mar 2009
Decision
87d
Days
Class 1
Risk

K083801 is an FDA 510(k) clearance for the BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70. 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 19, 2009 after a review of 87 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 - K083801

510(k) Number K083801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date March 19, 2009
Days to Decision 87 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
At panel average
Panel avg: 87d · This submission: 87d
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 K083801.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
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PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · Seju Engineering Co., Ltd. · Nov 2011
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
POCKET BREATHALYZER. CONNECTABLES
K052448 · Connectables, LLC · Feb 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332 · Sentech Korea Corp. · Jan 2006
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · Omega Point Systems, LLC · Dec 2005