Cleared Special

K090534 - VENOUS HARDSHELL CARDIOTOMY RESERVIORS

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

K090534 · Maquet Cardiopulmonary, AG · Cardiovascular device
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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.

View all Maquet Cardiopulmonary, AG devices

Submission Details

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.

Device Classification

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 120
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
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
K102919 · Maquet Cardiopulmonary, AG · Mar 2011
XRES BLOOD COLLECTION RESERVOIR
K100507 · Sorin Group Italia S.R.L. · Mar 2010
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
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