510(k) · Cleared
ClearedTri Stage Venous Cannulae
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 Sep 28, 2026 as substantially equivalent to K251258 (Medtronic, Inc., 2025) and 1 other predicate after a 102-day review. Its family tree reaches back 9 generations to 1984. 1 of the 81 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 28, 2026
- Review
- 102 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K840002 (1984). 80 ancestors in all, the oldest K790563 (1979). No later device cites it as a predicate yet. 1 of the 81 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
- 5 generations between
- 3 generations backK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
- 2 generations backK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
- 1 generation backK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
- This deviceK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
Show all 9 generations
- Root · 9 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
- 8 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
- 7 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
- 6 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
- 5 generations backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
- 4 generations backK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
- 3 generations backK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
- 2 generations backK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
- 1 generation backK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
- This deviceK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
Class I recalls in this family
- K834039 Infant Vent Catheter 12001 W/Side Vent5 generations back · 1984
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K840002 | Arterial Cannula Curved Beveled Tip | Dlp, Inc. | 1984 | 3 |
| −8 | K013013 | Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. | Medtronic Cardiac Surgical Products | 2001 | 1 |
| −7 | K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap… | Medtronic Perfusion Systems | 2003 | 2 |
| −6 | K043179 | Select 3D Arterial Cannula | Medtronic Perfusion Systems | 2005 | 1 |
| −5 | K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 | Medtronic Perfusion Systems | 2006 | — |
| −4 | K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia… | Medtronic, Inc. | 2011 | — |
| −3 | K120988 | DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula… | Medtronic, Inc. | 2012 | 2 |
| −2 | K140165 | MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall… | Medtronic, Inc. | 2014 | — |
| −1 | K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | Medtronic, Inc. | 2025 | — |
| 0 (this device) | K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 4 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 5 | 1 |
| 1985 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaSummary page 5…ices have the same fundamental scientific technology and intended use: Primary Predicate Device 510(k) Number: K251258 Device Trade Name: MC2X Three-stage Venous Cannulae Classification… | 2025 |
| * | K943934 | Aortic Arch CannulasSummary page 6…Page 1 Secondary Predicate Device 510(k) Number: K943934 Device Trade Name: Venous Return Cannulae Classification Name: Ca… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K834039Infant Vent Catheter 12001 W/Side VentDlp, Inc. · 1984 · 5 generations back · ◆ in the 1984 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 42 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 33 of the 80 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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 Tri Stage Venous Cannula is indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours.
The proposed patien population is Adults and Adolescents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262052: Tri Stage Venous Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262052
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026