Cleared Traditional

K062545 - RMI LCD ALCOHOL DETECTOR

K062545 is an FDA 510(k) clearance for RMI LCD ALCOHOL DETECTOR, manufactured by Resource Management International, LLC. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K062545 · Resource Management International, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
222d
Days
Class 1
Risk

K062545 is an FDA 510(k) clearance for the RMI LCD ALCOHOL DETECTOR. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Resource Management International, LLC (Waukegan, US). The FDA issued a Cleared decision on April 9, 2007 after a review of 222 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 Resource Management International, LLC devices

FDA 510(k) Submission Details - K062545

510(k) Number K062545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date April 09, 2007
Days to Decision 222 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
135d slower than avg
Panel avg: 87d · This submission: 222d
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 15
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K062545.
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
DRAEGER ALCOTEST 6510
K063443 · Drager Safety · Mar 2008
BACTRACK LCD ALCOHOL DETECTOR
K071067 · Khn Solutions, LLC · Sep 2007
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
K062971 · Akers Biosciences, Inc. · Dec 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · Sentech Korea Corp. · Oct 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K060343 · Sentech Korea Corp. · May 2006