Cleared Traditional

K203111 - Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

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

K203111 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K203111

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.

DTZ Device Classification - Class 2, Special Controls

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 235
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