Cleared Traditional

REDLINE ALCOHOL BREATH TESTER (K072953) - FDA 510(k) Clearance

Class I Toxicology device.

K072953 · Redline Products (Pty) , Ltd. · Toxicology device
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Jan 2008
Decision
81d
Days
Class 1
Risk

K072953 is an FDA 510(k) clearance for the REDLINE ALCOHOL BREATH TESTER. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Redline Products (Pty) , Ltd. (Strand Industria, Western Cape, ZA). The FDA issued a Cleared decision on January 7, 2008 after a review of 81 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 Redline Products (Pty) , Ltd. devices

Submission Details

510(k) Number K072953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2007
Decision Date January 07, 2008
Days to Decision 81 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 87d · This submission: 81d
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.