Cleared Traditional

K092463 - SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM

K092463 is an FDA 510(k) clearance for SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM, manufactured by Sorin Group Deutschland GmbH. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K092463 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
86d
Days
Class 2
Risk

K092463 is an FDA 510(k) clearance for the SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sorin Group Deutschland GmbH devices

FDA 510(k) Submission Details - K092463

510(k) Number K092463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2009
Decision Date November 05, 2009
Days to Decision 86 days
Submission Type Traditional
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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 34
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K092463.
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
SORIN C5 SYSTEM
K103762 · Sorin Group Deutschland GmbH · Jan 2011
SORIN C5 SYSTEM MODEL 58-00-00
K093882 · Sorin Group Deutschland GmbH · Jan 2010
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
K091007 · Sorin Group Deutschland GmbH · Jul 2009
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
K080832 · Sorin Group Deutschland GmbH · Jul 2008
MODIFICATION TO: STOCKERT S5 SYSTEM
K071318 · Sorin Group Deutschland GmbH · Jul 2007