Cleared Special

K090533 - HLM TUBING SET WITH SOFTLINE COATING

K090533 is an FDA 510(k) clearance for HLM TUBING SET WITH SOFTLINE COATING, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 294-day FDA review.

K090533 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
294d
Days
Class 2
Risk

K090533 is an FDA 510(k) clearance for the HLM TUBING SET WITH SOFTLINE COATING. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on December 18, 2009 after a review of 294 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 - K090533

510(k) Number K090533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2009
Decision Date December 18, 2009
Days to Decision 294 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 125d · This submission: 294d
Pathway characteristics
Modification to existing cleared device.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 397
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K090533 · HLM TUBING SET WITH SOFTLINE COATING
Download PDF FDA Summary Maquet Cardiopulmonar…