Cleared Traditional

K203111 - Affinity Fusion Oxygenator System

K203111 is the FDA 510(k) clearance for Affinity Fusion Oxygenator System by Medtronic. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K203111 · Medtronic · Cardiovascular device
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Sep 2021
Decision
336d
Days
Class 2
Risk

K203111 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on September 16, 2021 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtronic devices

Submission Details

510(k) Number K203111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2020
Decision Date September 16, 2021
Days to Decision 336 days
Submission Type Traditional
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
211d slower than avg
Panel avg: 125d · This submission: 336d
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 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K203111.
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
K212341 · Qura S.R.L · Jan 2022
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
K203424 · Qura S.R.L · Dec 2021
AMG PMP Infant
K202510 · Eurosets S.R.L · Dec 2021
EOS PMP
K211495 · Sorin Group Italia S.R.L. · Jul 2021
AMG PMP Pediatric
K202206 · Eurosets S.R.L · Apr 2021
OXY-1 System
K200109 · Abiomed, Inc. · Oct 2020