Cleared Traditional

Affinity NT Oxygenator with Cortiva BioActive Surface (K162016) - FDA 510(k) Clearance

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

K162016 · Medtronic, Inc. · Cardiovascular device
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Sep 2016
Decision
62d
Days
Class 2
Risk

K162016 is an FDA 510(k) clearance for the Affinity NT Oxygenator with Cortiva BioActive Surface. 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 September 21, 2016 after a review of 62 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 K162016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date September 21, 2016
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 98
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K162016.
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 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 · Medtronic, Inc. · Oct 2017
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · Medtronic, Inc. · Dec 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
K142784 · Medtronic, Inc. · Oct 2014
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
K123314 · Medtronic, Inc. · Jan 2013