Cleared Traditional

K894721 - TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE

K894721 is the FDA 510(k) clearance for TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE by The Traumafuse Co.. It is a Class 2 Cardiovascular device (product code DWE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K894721 · The Traumafuse Co. · Cardiovascular device
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Oct 1989
Decision
87d
Days
Class 2
Risk

K894721 is an FDA 510(k) clearance for the TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by The Traumafuse Co. (Allentown, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Traumafuse Co. devices

Submission Details

510(k) Number K894721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date October 20, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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

Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K894721.
SMARxT Tubing and Connectors
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SARNS TEMPERATURE PROBE AND CONNECTOR
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SARNS EVACUPLEGE CATHETER
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MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · Medrad, Inc. · Apr 1981
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
K800178 · Extracorporeal Medical Specialities, Inc. · Feb 1980