Cleared Special

K141233 - AFFINITY PIXIE OXYGENATION SYSTEM WITH

Also marketed or referenced as:
CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE

K141233 is an FDA 510(k) clearance for AFFINITY PIXIE OXYGENATION SYSTEM WITH, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 30-day FDA review.

K141233 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
30d
Days
Class 2
Risk

K141233 is an FDA 510(k) clearance for the AFFINITY PIXIE OXYGENATION SYSTEM WITH. 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 June 12, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K141233

510(k) Number K141233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date June 12, 2014
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 140
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K141233.
Capiox Advance Hardshell Reservoir
K153143 · Terumo Cardiovascular Systems Corporation · Dec 2015
Intersept Filtered Cardiotomy Reservoir
K151110 · Medtronic, Inc. · May 2015
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
K141432 · Maquet Cardiopulmonary, AG · Jul 2014
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