510(k) · Cleared
ClearedEasyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 27, 2025 as substantially equivalent to K060101 (Endoscopic Technologies, Inc., 2006) and 1 other predicate after a 119-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jun 27, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K845045 (1985). 15 ancestors in all, the oldest K831769 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
- 4 generations backK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
- 3 generations backK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
- 2 generations backK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
- 1 generation backK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
- This deviceK250610 Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K845045 | Venous Return Catheter SS-1 | Dlp, Inc. | 1985 | 3 |
| −4 | K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | Medtronic Perfusion Systems | 2003 | — |
| −3 | K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | Estech, Inc. | 2005 | 1 |
| −2 | K060101 | Estech Aortic Easy Flow Cannula | Endoscopic Technologies, Inc. | 2006 | — |
| −1 | K091542 | Estech Easyflow Cannula with Guidewire | Endoscopic Technologies, Inc. D/B/A Estech | 2009 | — |
| 0 (this device) | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060101 | Estech Aortic Easy Flow CannulaSummary page 6…. Both modified and unmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K060101 Device Trade Name: Easyflow Aortic Cannula Classification Name:… | 2006 |
| * | K091542 | Estech Easyflow Cannula with GuidewireSummary page 6…Classification: Class II Classification Panel: Cardiovascular 510(k) Number: K091542 Easyflow Device Trade Name: Easyflow Cannula with guidewire Duo… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K060101.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026