Cleared Traditional

K950990 - STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

K950990 is an FDA 510(k) clearance for STOCKERT S3 ROLLER PUMP MODULE STOCKERT..., manufactured by Stoeckert Instrumente. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K950990

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
Combination Product No
PCCP Authorized No
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.

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 41
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K950990.
STOCKERT COMPACT SYSTEM
K982014 · Stoeckert Instrumente · Sep 1998
AFFINITY BLOOD PUMP SYSTEM
K964017 · Avecor Cardiovascular, Inc. · Aug 1997
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
K943803 · Janus Biomedical, Inc. · Jan 1996
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