Cleared Traditional

K160613 - Soberlink Cellular Device and Sober Sky Web Portal (FDA 510(k) Clearance)

Class I Toxicology device.

K160613 · Soberlink Healthcare, LLC · Toxicology device
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Jul 2016
Decision
133d
Days
Class 1
Risk

K160613 is an FDA 510(k) clearance for the Soberlink Cellular Device and Sober Sky Web Portal. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Soberlink Healthcare, LLC (Huntington Beach, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 133 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 Soberlink Healthcare, LLC devices

Submission Details

510(k) Number K160613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2016
Decision Date July 14, 2016
Days to Decision 133 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
46d slower than avg
Panel avg: 87d · This submission: 133d
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.