Cleared Traditional

K262052 - Tri Stage Venous Cannulae

K262052 is an FDA 510(k) clearance for Tri 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 Traditional 510(k) pathway after a 102-day FDA review.

K262052 · Sorin Group Italia S.R.L. · Cardiovascular device
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Sep 2026
Decision
102d
Days
Class 2
Risk

K262052 is an FDA 510(k) clearance for the Tri 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 September 28, 2026 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K262052

510(k) Number K262052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2026
Decision Date September 28, 2026
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K262052.
Dual Stage Venous Cannulae
K263092 · Sorin Group Italia S.R.L. · Oct 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