Cleared Traditional

K140938 - OSTOM-I ALERT

K140938 is an FDA 510(k) clearance for OSTOM-I ALERT, manufactured by 11 Health and Technologies, LLC. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K140938 · 11 Health and Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K140938

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.

EXB Device Classification - Class 1, General Controls

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.

Regulatory Peers - EXB Collector, Ostomy

All 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K140938.
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