Cleared Traditional

K103302 - STEMPRO MSC SFM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103302 · Life Technologies Corporation · Gastroenterology & Urology device
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Feb 2011
Decision
101d
Days
Class 2
Risk

K103302 is an FDA 510(k) clearance for the STEMPRO MSC SFM. Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Life Technologies Corporation (Grand Island, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - 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.

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Submission Details

510(k) Number K103302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2010
Decision Date February 18, 2011
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDS Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.