Cleared Special

K132166 - VENOUS HARDSHELL CARDIOTOMY RESERVOIR

Also marketed or referenced as:
NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT

K132166 is an FDA 510(k) clearance for VENOUS HARDSHELL CARDIOTOMY RESERVOIR, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 110-day FDA review.

K132166 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
110d
Days
Class 2
Risk

K132166 is an FDA 510(k) clearance for the VENOUS HARDSHELL CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on October 30, 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132166

510(k) Number K132166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2013
Decision Date October 30, 2013
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 167
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K132166.
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
K141432 · Maquet Cardiopulmonary, AG · Jul 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · Medtronic, Inc. · Jun 2014
INITARY BETTER BLADDER-PEDIATRIC
K140321 · Circulatory Technology, Inc. · Apr 2014
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
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
K122914 · Medtronic, Inc. · Jan 2013
K132166 · VENOUS HARDSHELL CARDIOTOMY RESERVOIR
Download PDF FDA Summary Maquet Cardiopulmonar…