Cleared Traditional

Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir (K172626) - FDA 510(k) Clearance

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

K172626 · Medtronic, Inc. · Cardiovascular device
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Oct 2017
Decision
54d
Days
Class 2
Risk

K172626 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenato.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K172626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date October 25, 2017
Days to Decision 54 days
Submission Type Traditional
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
71d faster than avg
Panel avg: 125d · This submission: 54d
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 97
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K172626.
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
K172071 · Terumo Cardiovascular Systems Corporation · Mar 2018
INSPIRE 6M Hollow Fiber Oxygenator
K180448 · Sorin Group Italia S.R.L. · Mar 2018
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
K172984 · Medtronic, Inc. · Nov 2017
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · Medtronic, Inc. · Dec 2016
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · Medtronic, Inc. · Sep 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015