Cleared Traditional

K955038 - STOCKERT S3 DOUBLE HEAD PUMP MODULE

K955038 is the FDA 510(k) clearance for STOCKERT S3 DOUBLE HEAD PUMP MODULE by Stoeckert Instrumente. It is a Class 2 Cardiovascular device (product code DWB) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K955038 · Stoeckert Instrumente · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
110d
Days
Class 2
Risk

K955038 is an FDA 510(k) clearance for the STOCKERT S3 DOUBLE HEAD PUMP MODULE. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 Stoeckert Instrumente devices

Submission Details

510(k) Number K955038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1995
Decision Date February 21, 1996
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 14
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K955038.
COBE CENTURY PERFUSION PUMP
K960974 · Cobe Cardiovascular, Inc. · Jul 1997
SARNS 800 ROLLER PUMP
K953901 · 3M Health Care, Sarns · Apr 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904 · 3M Health Care, Ltd. · Apr 1996
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · Shiley, Inc. · Apr 1989
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · Shiley, Inc. · Jul 1986