Cleared Traditional

K090689 - QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090689 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Oct 2009
Decision
227d
Days
Class 2
Risk

K090689 is an FDA 510(k) clearance for the QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTL.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on October 29, 2009 after a review of 227 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K090689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date October 29, 2009
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 253
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