Cleared Traditional

K955038 - STOCKERT S3 DOUBLE HEAD PUMP MODULE

K955038 is an FDA 510(k) clearance for STOCKERT S3 DOUBLE HEAD PUMP MODULE, manufactured by Stoeckert Instrumente. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K955038

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
Combination Product No
PCCP Authorized No
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.

DWB Device Classification - Class 2, Special Controls

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 18
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
ANGIOMED INTRODUCING SETS
K874771 · Angiomed U.S., Inc. · Jan 1988
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986