Cleared Traditional

K020571 - STOCKERT CENTRIFUGAL PUMP CONSOLE

K020571 is an FDA 510(k) clearance for STOCKERT CENTRIFUGAL PUMP CONSOLE, manufactured by Stockert Instrumente GmbH. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K020571 · Stockert Instrumente GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
214d
Days
Class 2
Risk

K020571 is an FDA 510(k) clearance for the STOCKERT CENTRIFUGAL PUMP CONSOLE. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Stockert Instrumente GmbH (North Attleboro, US). The FDA issued a Cleared decision on September 23, 2002 after a review of 214 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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.

FDA 510(k) Submission Details - K020571

510(k) Number K020571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2002
Decision Date September 23, 2002
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 49
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K020571.
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
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MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
K030141 · Cardiovention, Inc. · Feb 2003
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
K021694 · Cardiovention, Inc. · Jan 2003
SIII ALARM AMPLIFIER
K011088 · Stockert Instrumente GmbH · May 2001
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116 · Medical Device Consultants, Inc. · Aug 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118 · Stoeckert Instrumente · Aug 2000
K020571 · STOCKERT CENTRIFUGAL PUMP CONSOLE
Download PDF FDA Summary Stockert Instrumente …