Cleared Traditional

K011838 - CENTRIFUGAL PUMP

K011838 is an FDA 510(k) clearance for CENTRIFUGAL PUMP, manufactured by Stockert Instrumente GmbH. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K011838 · Stockert Instrumente GmbH · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K011838

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.

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 18
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K011838.
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369 · Cardiacassist, Inc. · Aug 2006
BIO-CONSOLE, MODEL 560
K051303 · Medtronic Perfusion Systems · Jun 2005
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739 · 3M Health Care, Sarns · Nov 1995
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · Gambro, Inc. · Aug 1984