Cleared Traditional

K101046 - STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (FDA 510(k) Clearance)

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

K101046 · Sorin Group Deutschland GmbH · Cardiovascular device
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Dec 2010
Decision
239d
Days
Class 2
Risk

K101046 is an FDA 510(k) clearance for the STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM. Classified as Gas Control Unit, Cardiopulmonary Bypass (product code DTX), Class II - Special Controls.

Submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 239 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4300 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K101046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date December 09, 2010
Days to Decision 239 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTX Gas Control Unit, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4300
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 Cardiovascular devices follow this clearance model.