Cleared Traditional

K140938 - OSTOM-I ALERT (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K140938 · 11 Health and Technologies, LLC · Gastroenterology & Urology device
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Oct 2014
Decision
182d
Days
Class 1
Risk

K140938 is an FDA 510(k) clearance for the OSTOM-I ALERT. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by 11 Health and Technologies, LLC (Crofton, US). The FDA issued a Cleared decision on October 10, 2014 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all 11 Health and Technologies, LLC devices

Submission Details

510(k) Number K140938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2014
Decision Date October 10, 2014
Days to Decision 182 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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.