Cleared Special

K080592 - HLM TUBING SET WITH BIOLINE COATING

K080592 is an FDA 510(k) clearance for HLM TUBING SET WITH BIOLINE COATING, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DWE cleared through the Special 510(k) pathway after a 192-day FDA review.

K080592 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Sep 2008
Decision
192d
Days
Class 2
Risk

K080592 is an FDA 510(k) clearance for the HLM TUBING SET WITH BIOLINE COATING. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on September 11, 2008 after a review of 192 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maquet Cardiopulmonary, AG devices

FDA 510(k) Submission Details - K080592

510(k) Number K080592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date September 11, 2008
Days to Decision 192 days
Submission Type Special
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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Modification to existing cleared device.

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 14
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K080592.
SMARxT Tubing and Connectors
K233702 · LivaNova USA, Inc. · Aug 2024
Terumo Pump Tubing
K150542 · Terumo Cardiovascular Systems Corporation · May 2015
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
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
K993189 · Terumo Corp. · Mar 2000