510(k) · Cleared
Recalled · Class II · 2024DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jul 25, 2012 as substantially equivalent to K842375 (Dlp, Inc., 1984) and 3 other predicates after a 114-day review. Its family tree reaches back 6 generations to 1984. 1 of the 81 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 25, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K840002 (1984). 76 ancestors in all, the oldest K790563 (1979). 4 later devices descend from it, 2 citing it directly. 1 of the 81 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
- 5 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
- 4 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
- 3 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
- 2 generations backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
- 1 generation backK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
- This deviceK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
- Descendant · cites it directly · 0 of its ownK250937 Venous Return CannulaeLivaNova USA, Inc. · 2026
Class I recalls in this family
- K834039 Infant Vent Catheter 12001 W/Side Vent2 generations back · 1984
Most influential descendants
Showing 4 of 4 · See all- K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · cites it directly2descendants
- K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 2 generations on1descendant
- K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 3 generations on0descendants
- K250937Venous Return CannulaeLivaNova USA, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K840002 | Arterial Cannula Curved Beveled Tip | Dlp, Inc. | 1984 | 3 |
| −5 | K013013 | Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. | Medtronic Cardiac Surgical Products | 2001 | 1 |
| −4 | K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap… | Medtronic Perfusion Systems | 2003 | 2 |
| −3 | K043179 | Select 3D Arterial Cannula | Medtronic Perfusion Systems | 2005 | 1 |
| −2 | K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 | Medtronic Perfusion Systems | 2006 | — |
| −1 | K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia… | Medtronic, Inc. | 2011 | — |
| 0 (this device) | K120988 | DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula… | Medtronic, Inc. | 2012 | — |
| +1 | K140165 | MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall… | Medtronic, Inc. | 2014 | — |
| +2 | K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | Medtronic, Inc. | 2025 | — |
| +3 | K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026 | — |
| +1 | K250937 | Venous Return Cannulae | LivaNova USA, Inc. | 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 | 2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K842375 | Venous Cannula W/Bent, Tip Wire Our reading of the summary gave K842374, FDA’s number for Novametrix 850 Transcutaneous Oxygen (Novametrix Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Venous Cannula with Bent Tip Wire”. | 1984 |
| * | K022272 | Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Summary page 1…ber: 21 CFR 870.42 10 Product Code: DWF Product Class 11 Classification: Predicate Devices K842374 Venous Cannula with Bent, Tip Wire K022272 Malleable Single Stage Venous Cannula Kl111972 Malleable Single Stage Venous Cannula with Carmeda… | 2003 |
| * | K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Summary page 1…Class 11 Classification: Predicate Devices K842374 Venous Cannula with Bent, Tip Wire K022272 Malleable Single Stage Venous Cannula Kl111972 Malleable Single Stage Venous Cannula with Carmeda BioActive Surface Device Desc… | 2011 |
| * | K845045 | Venous Return Catheter SS-1Summary page 2…extended terms such as Ventricular Assist procedures. Comparison to Predicate Devices A comparison of the modified product to the currently marketed predicate product (K845045 and K022272) indicate the following similarities: "Same intended use " Same technological characteristics * Same… | 1985 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2024 | Class II | Z-3128-2024 | Under Investigation by firm | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). |
| Feb 19, 2013 | Class II | Z-0908-2013 | Nonconforming Material/Component | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. |
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 · 2 generations back · ◆ in the 1984 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 31 of the 76 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140165 (Medtronic, Inc., 2014) has gone furthest, with 2 descendants of its own.
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. 2012, 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?
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava, during cardiopulmonary bypass surgery up to six hours of less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120988
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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