Cleared Special

K092315 - SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

K092315 is an FDA 510(k) clearance for SORIN VVR 4000I AND 4000I SMARXT FILTER..., 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 13-day FDA review.

K092315 · 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
Aug 2009
Decision
13d
Days
Class 2
Risk

K092315 is an FDA 510(k) clearance for the SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on August 12, 2009 after a review of 13 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 - K092315

510(k) Number K092315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2009
Decision Date August 12, 2009
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
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 168
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K092315.
XRES BLOOD COLLECTION RESERVOIR
K100507 · Sorin Group Italia S.R.L. · Mar 2010
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
K090534 · Maquet Cardiopulmonary, AG · Dec 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K090690 · Maquet Cardiopulmonary, AG · Dec 2009
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
K092315 · SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
Download PDF FDA Summary Sorin Group Italia S.…