K260043 is an FDA 510(k) clearance for the Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C). This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K260043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | DWF - Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |