Cleared Traditional

K841959 - CARDIO METRIC CUSTOM PERFUSION TUBING

K841959 is the FDA 510(k) clearance for CARDIO METRIC CUSTOM PERFUSION TUBING by Sterile Design, Inc.. It is a Class 2 Cardiovascular device (product code DWE) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K841959 · Sterile Design, Inc. · Cardiovascular device
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Oct 1984
Decision
158d
Days
Class 2
Risk

K841959 is an FDA 510(k) clearance for the CARDIO METRIC CUSTOM PERFUSION TUBING. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Sterile Design, Inc. (Oldsmar, US). The FDA issued a Cleared decision on October 19, 1984 after a review of 158 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4390 - 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 Sterile Design, Inc. devices

Submission Details

510(k) Number K841959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date October 19, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWE Tubing, Pump, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4390
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 - DWE Tubing, Pump, Cardiopulmonary Bypass

All 10
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K841959.
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002
COBE SMARXT TUBING AND CONNECTORS
K981613 · Cobe Cardiovascular, Inc. · Oct 1998
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991
SARNS EVACUPLEGE CATHETER
K842044 · 3M Health Care, Sarns · Aug 1984
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · Medrad, Inc. · Apr 1981
TYGON TUBING
K803277 · Electromedics, Inc. · Jan 1981