Cleared Traditional

K102338 - BREATHSCN PRO

K102338 is an FDA 510(k) clearance for BREATHSCN PRO, manufactured by Akers Biosciences, Inc.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K102338 · Akers Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
147d
Days
Class 1
Risk

K102338 is an FDA 510(k) clearance for the BREATHSCN PRO. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Akers Biosciences, Inc. (Thorofare, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 147 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K102338

510(k) Number K102338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2010
Decision Date January 12, 2011
Days to Decision 147 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
60d slower than avg
Panel avg: 87d · This submission: 147d
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 27
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K102338.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470 · Pas Systems International, Inc. · Apr 2013
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · Seju Engineering Co., Ltd. · Nov 2011
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
K102225 · Alcopro, Inc. · Apr 2011
CONTRALCO
K100879 · Contralco · Aug 2010
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714 · Skyfine Inc. Limited · Nov 2009
K102338 · BREATHSCN PRO
Download PDF FDA Summary Akers Biosciences, In…