Cleared Traditional

K113313 - MOLECULAR ADSORBENT RECIRCULATING(MARS) (FDA 510(k) Clearance)

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

K113313 · Gambro Renal Products, Inc. · Gastroenterology & Urology device
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Dec 2012
Decision
401d
Days
Class 2
Risk

K113313 is an FDA 510(k) clearance for the MOLECULAR ADSORBENT RECIRCULATING(MARS). Classified as Apparatus, Hemoperfusion, Sorbent (product code FLD), Class II - Special Controls.

Submitted by Gambro Renal Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5870 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Gambro Renal Products, Inc. devices

Submission Details

510(k) Number K113313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date December 14, 2012
Days to Decision 401 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
271d slower than avg
Panel avg: 130d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLD Apparatus, Hemoperfusion, Sorbent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5870
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.