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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 19
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K080592.
Terumo Pump Tubing
K150542 · Terumo Cardiovascular Systems Corporation · May 2015
AngioVac Circuit
K142607 · Angiodynamics · Dec 2014
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
K092486 · Vortex Medical, Inc. · Aug 2009
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
K080592 · HLM TUBING SET WITH BIOLINE COATING
Download PDF FDA Summary Maquet Cardiopulmonar…