Cleared Traditional

K053332 - BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500

K053332 is an FDA 510(k) clearance for BREATH ALCOHOL TEST SYSTEM, manufactured by Sentech Korea Corp.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K053332 · Sentech Korea Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
50d
Days
Class 1
Risk

K053332 is an FDA 510(k) clearance for the BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Sentech Korea Corp. (Palisades Park, US). The FDA issued a Cleared decision on January 20, 2006 after a review of 50 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 Sentech Korea Corp. devices

FDA 510(k) Submission Details - K053332

510(k) Number K053332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date January 20, 2006
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 8
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K053332.
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
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · Omega Point Systems, LLC · Dec 2005
ALCOHAWK PRECISION
K043188 · Q3 Innovations, LLC · Feb 2005
ALCOMATE, MODEL CA2000
K041334 · Khn Solutions, LLC · Aug 2004