Cleared Traditional

RMI LCD ALCOHOL DETECTOR (K062545) - FDA 510(k) Clearance

Class I Toxicology device.

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

Submission Details

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.

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.