Cleared Traditional

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

K260043 · Smart Reactors · Cardiovascular

Feb 2026

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K260043 is an FDA 510(k) clearance for the Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Smart Reactors (Galway, IE). The FDA issued a Cleared decision on February 23, 2026, 47 days after receiving the submission on January 7, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K260043 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2026
Decision Date	February 23, 2026
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

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