# K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 27, 2025 after 119 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K845045 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060101: Estech Aortic Easy Flow Cannula, Endoscopic Technologies, Inc. (2006) Summary page 6.
- K091542: Estech Easyflow Cannula with Guidewire, Endoscopic Technologies, Inc. D/B/A Estech (2009) Summary page 6.

## Indications for use
The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours. The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.

Source page: https://510kreport.com/device/K250610
Methodology: https://510kreport.com/methodology