Cleared Traditional

K122914 - AFFINITY FUSION CARDIOTOMY/VENOUS RESER...

K122914 is the FDA 510(k) clearance for AFFINITY FUSION CARDIOTOMY/VENOUS RESER... by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K122914 · Medtronic, Inc. · Cardiovascular device
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Jan 2013
Decision
110d
Days
Class 2
Risk

K122914 is an FDA 510(k) clearance for the AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB8.... Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 9, 2013 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Medtronic, Inc. devices

Submission Details

510(k) Number K122914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date January 09, 2013
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 77
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K122914.
Intersept Filtered Cardiotomy Reservoir
K151110 · Medtronic, Inc. · May 2015
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · Medtronic, Inc. · Jun 2014
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · Medtronic, Inc. · Oct 2013
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · Gish Biomedical, Inc. · Aug 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
K083131 · Gish Biomedical, Inc. · Jul 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · Gish Biomedical, Inc. · Feb 2009