Cleared Special

K131103 - XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR

K131103 is an FDA 510(k) clearance for XRES BLOOD COLLECTION RESERVOIR XRES 12..., manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 48-day FDA review.

K131103 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
48d
Days
Class 2
Risk

K131103 is an FDA 510(k) clearance for the XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Arvada, US). The FDA issued a Cleared decision on June 6, 2013 after a review of 48 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.

FDA 510(k) Submission Details - K131103

510(k) Number K131103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2013
Decision Date June 06, 2013
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 164
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K131103.
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K122914 · Medtronic, Inc. · Jan 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
K131103 · XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Download PDF FDA Summary Sorin Group Italia S.…