Cleared Traditional

CENTRIFUGAL PUMP (K011838) - FDA 510(k) Clearance

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

K011838 · Stockert Instrumente GmbH · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
238d
Days
Class 2
Risk

K011838 is an FDA 510(k) clearance for the CENTRIFUGAL PUMP. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Stockert Instrumente GmbH (North Attleboro, US). The FDA issued a Cleared decision on February 5, 2002 after a review of 238 days - an extended review 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: 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.

View all Stockert Instrumente GmbH devices

Submission Details

510(k) Number K011838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date February 05, 2002
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K011838.
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
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952 · Medtronic Vascular · Aug 1978