Cleared Special

K060053 - STOCKERT S5 SYSTEM

K060053 is an FDA 510(k) clearance for STOCKERT 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 147-day FDA review.

K060053 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
147d
Days
Class 2
Risk

K060053 is an FDA 510(k) clearance 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 June 2, 2006 after a review of 147 days - within the typical 510(k) review window.

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. 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 - K060053

510(k) Number K060053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date June 02, 2006
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 K060053.
MODIFICATION TO: STOCKERT S5 SYSTEM
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