Cleared Traditional

K122914 - AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE

K122914 is an FDA 510(k) clearance for AFFINITY FUSION CARDIOTOMY/VENOUS RESER..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K122914

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.

DTN Device Classification - Class 2, Special Controls

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 143
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K122914.
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
K132166 · Maquet Cardiopulmonary, AG · Oct 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · Medtronic, Inc. · Oct 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
K131103 · Sorin Group Italia S.R.L. · Jun 2013
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · Sorin Group Italia S.R.L. · Oct 2011
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
K102919 · Maquet Cardiopulmonary, AG · Mar 2011
XRES BLOOD COLLECTION RESERVOIR
K100507 · Sorin Group Italia S.R.L. · Mar 2010