Cleared Special

K100507 - XRES BLOOD COLLECTION RESERVOIR

K100507 is an FDA 510(k) clearance for XRES BLOOD COLLECTION RESERVOIR, 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 30-day FDA review.

K100507 · Sorin Group Italia S.R.L. · Cardiovascular device
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Mar 2010
Decision
30d
Days
Class 2
Risk

K100507 is an FDA 510(k) clearance for the XRES BLOOD COLLECTION 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 March 24, 2010 after a review of 30 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 - K100507

510(k) Number K100507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date March 24, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 167
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K100507.
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K092315 · Sorin Group Italia S.R.L. · Aug 2009
K100507 · XRES BLOOD COLLECTION RESERVOIR
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