Cleared Traditional

K993189 - CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING

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

K993189 · Terumo Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993189

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
Combination Product No
PCCP Authorized No
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.

DWE Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K993189.
JOSTRA HLM TUBING SET
K053025 · Maquet Cardiopulmonary, AG · Nov 2005
PUMP TUBING WITH X-COATING
K022857 · Terumo Cardiovascular Systems Corporation · Sep 2002
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002
CHEST DRAINAGE TUBING
K993062 · Olson Medical Sales, Inc. · Dec 1999
COBE SMARXT TUBING AND CONNECTORS
K981613 · Cobe Cardiovascular, Inc. · Oct 1998
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991