Cleared Traditional

K103468 - STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (C...

K103468 is an FDA 510(k) clearance for STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (C..., manufactured by Sorin Group Deutschland GmbH. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K103468 · Sorin Group Deutschland GmbH · Cardiovascular device
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Jan 2011
Decision
57d
Days
Class 2
Risk

K103468 is an FDA 510(k) clearance for the STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS). Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sorin Group Deutschland GmbH devices

FDA 510(k) Submission Details - K103468

510(k) Number K103468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date January 20, 2011
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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.

Regulatory Peers - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 17
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K103468.
CentriMag Acute Circulatory Support System
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BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · Medtronic, Inc. · Jul 2013
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · Sorin Group Deutschland GmbH · Sep 2011
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · Sorin Group Deutschland GmbH · Jul 2009
BIO-CONSOLE 560
K080824 · Medtronic Perfusion Systems · May 2008
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007