Cleared Special

K091007 - AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

K091007 is an FDA 510(k) clearance for AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM ..., manufactured by Sorin Group Deutschland GmbH. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Special 510(k) pathway after a 84-day FDA review.

K091007 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
84d
Days
Class 2
Risk

K091007 is an FDA 510(k) clearance for the AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05. 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 July 2, 2009 after a review of 84 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. 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 - K091007

510(k) Number K091007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date July 02, 2009
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 48
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K091007.
SORIN C5 SYSTEM MODEL 58-00-00
K093882 · Sorin Group Deutschland GmbH · Jan 2010
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
K092463 · Sorin Group Deutschland GmbH · Nov 2009
LIFEBRIDGE B2T, MODEL 7001
K090006 · Lifebridge Medizintechnik AG · Oct 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
PERFORMER CBP SYSTEM
K070213 · Rand S.R.L. · Mar 2007