Cleared Special

K263092 - Dual Stage Venous Cannulae

K263092 is an FDA 510(k) clearance for Dual Stage Venous Cannulae, manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 28-day FDA review.

K263092 · Sorin Group Italia S.R.L. · Cardiovascular device
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Oct 2026
Decision
28d
Days
Class 2
Risk

K263092 is an FDA 510(k) clearance for the Dual Stage Venous Cannulae. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on October 1, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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.

View all Sorin Group Italia S.R.L. devices

FDA 510(k) Submission Details - K263092

510(k) Number K263092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2026
Decision Date October 01, 2026
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 365
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K263092.
Tri Stage Venous Cannulae
K262052 · Sorin Group Italia S.R.L. · Sep 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · Medtronic, Inc. · Apr 2026
Venous Return Cannulae
K250937 · LivaNova USA, Inc. · Mar 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
K260043 · Smart Reactors · Feb 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · Medtronic, Inc. · Feb 2026
Dual Stage Venous Cannulae
K253671 · Sorin Group Italia S.R.L. · Jan 2026