Cleared Traditional

BREATHSCN PRO (K102338) - FDA 510(k) Clearance

Class I Toxicology device.

K102338 · Akers Biosciences, Inc. · Toxicology device
Download Printable Device Report (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.

View all Akers Biosciences, Inc. devices

Submission Details

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.

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.