Cleared Special

K112225 - SORIN CENTRIFUGAL PUMP 5 (CP5)

K112225 is an FDA 510(k) clearance for SORIN CENTRIFUGAL PUMP 5 (CP5), manufactured by Sorin Group Deutschland GmbH. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Special 510(k) pathway after a 48-day FDA review.

K112225 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
48d
Days
Class 2
Risk

K112225 is an FDA 510(k) clearance for the SORIN CENTRIFUGAL PUMP 5 (CP5). 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 September 20, 2011 after a review of 48 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sorin Group Deutschland GmbH devices

FDA 510(k) Submission Details - K112225

510(k) Number K112225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2011
Decision Date September 20, 2011
Days to Decision 48 days
Submission Type Special
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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 K112225.
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306 · Abbott (Formerly Thoratec Corporation) · Mar 2020
CentriMag Acute Circulatory Support System
K191557 · Thoratec Corporation (Now Part of Abbott) · Jul 2019
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · Medtronic, Inc. · Jul 2013
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · Sorin Group Deutschland GmbH · Jan 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