Cleared Traditional

K993189 - CARDIOPULMONARY BYPASS PUMP TUBING - 1/...

K993189 is the FDA 510(k) clearance for CARDIOPULMONARY BYPASS PUMP TUBING - 1/... by Terumo Corp.. It is a Class 2 Cardiovascular device (product code DWE) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K993189 · Terumo Corp. · Cardiovascular device
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Mar 2000
Decision
160d
Days
Class 2
Risk

K993189 is an FDA 510(k) clearance for the CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS .... Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 160 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 Terumo Corp. devices

Submission Details

510(k) Number K993189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1999
Decision Date March 01, 2000
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
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 9
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K993189.
HLM TUBING SET WITH BIOLINE COATING
K080592 · Maquet Cardiopulmonary, AG · Sep 2008
JOSTRA HLM TUBING SET
K053025 · Maquet Cardiopulmonary, AG · Nov 2005
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