Cleared Traditional

K950990 - STOCKERT S3 ROLLER PUMP MODULE STOCKERT...

K950990 is the FDA 510(k) clearance for STOCKERT S3 ROLLER PUMP MODULE STOCKERT... by Stoeckert Instrumente. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K950990 · Stoeckert Instrumente · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1996
Decision
322d
Days
Class 2
Risk

K950990 is an FDA 510(k) clearance for the STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on January 19, 1996 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Stoeckert Instrumente devices

Submission Details

510(k) Number K950990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date January 19, 1996
Days to Decision 322 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
197d slower than avg
Panel avg: 125d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K950990.
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · 3M Health Care, Sarns · Jul 1992
SARNS 9000 HEART-LUNG CONSOLE
K871131 · 3M Health Care, Sarns · May 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · Cobe Laboratories, Inc. · May 1987