Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)— 510(k) K260043

Substantially Equivalent

Smart Reactors

FDA 510(k) clearance K260043 for Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C), Substantially Equivalent on 2026-02-23. Applicant: Smart Reactors.

Clearance details

Applicant: Smart Reactors
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2026-01-07
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.