510(k) · Cleared
ClearedEstech Aortic Easy Flow Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoscopic Technologies, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 10, 2006 as substantially equivalent to K934127 (3M Health Care, Sarns, 1994) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1985. 2 of the 14 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K845045 (1985). 7 ancestors in all. 6 later devices descend from it, 3 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
- 2 generations backK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
- 1 generation backK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
- This deviceK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
- Descendant · cites it directly · 0 of its ownK250610 Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025
- Descendant · 3 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · cites it directly3descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
- K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009 · cites it directly1descendant
- K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025 · cites it directly0descendants
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K845045 | Venous Return Catheter SS-1 | Dlp, Inc. | 1985 | 3 |
| −2 | K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | Medtronic Perfusion Systems | 2003 | — |
| −1 | K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | Estech, Inc. | 2005 | 1 |
| 0 (this device) | K060101 | Estech Aortic Easy Flow Cannula | Endoscopic Technologies, Inc. | 2006 | — |
| +1 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +1 | K091542 | Estech Easyflow Cannula with Guidewire | Endoscopic Technologies, Inc. D/B/A Estech | 2009 | — |
| +1 | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025 | — |
| +3 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2025 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K934127 | Sarns Low Jetting Aortic Arch CannulaSummary page 1…e Proprietary Name: ESTECH Aortic Easy Flow Cannula Predicate Device Information: Predicate Devices: Low Jetting Aortic Arch Cannula (K934127) ESTECH Remote Access Perfusion FV Cannul… | 1994 |
| * | K052081 | Remote Access Perfusion (Rap) Femoral Venous CannulaSummary page 1…Jetting Aortic Arch Cannula (K934127) ESTECH Remote Access Perfusion FV Cannula (K052081) Predicate Device Manufacturers: Sams a division of Terumo ESTECH, Inc. P… | 2005 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K083111 (Abiomed, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K934127.
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.
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 ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060101: Estech Aortic Easy Flow Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060101
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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