Cleared Special

K090534 - VENOUS HARDSHELL CARDIOTOMY RESERVIORS

K090534 is an FDA 510(k) clearance for VENOUS HARDSHELL CARDIOTOMY RESERVIORS, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 299-day FDA review.

K090534 · 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
299d
Days
Class 2
Risk

K090534 is an FDA 510(k) clearance for the VENOUS HARDSHELL CARDIOTOMY RESERVIORS. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on December 23, 2009 after a review of 299 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 - K090534

510(k) Number K090534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2009
Decision Date December 23, 2009
Days to Decision 299 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
174d slower than avg
Panel avg: 125d · This submission: 299d
Pathway characteristics
Modification to existing cleared device.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 167
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K090534.
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · Sorin Group Italia S.R.L. · Oct 2011
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K102919 · Maquet Cardiopulmonary, AG · Mar 2011
XRES BLOOD COLLECTION RESERVOIR
K100507 · Sorin Group Italia S.R.L. · Mar 2010
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K090690 · Maquet Cardiopulmonary, AG · Dec 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K092315 · Sorin Group Italia S.R.L. · Aug 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · Gish Biomedical, Inc. · Aug 2009
K090534 · VENOUS HARDSHELL CARDIOTOMY RESERVIORS
Download PDF FDA Summary Maquet Cardiopulmonar…