510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.

K013013510(k) TraditionalCleared Dec 4, 200188-day reviewClass II21 CFR 870.4210Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Cardiac Surgical Products · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Dec 4, 2001 as substantially equivalent to K840002 (Dlp, Inc., 1984) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1984. 12 later devices descend from it. It has been recalled once.

Decided
Dec 4, 2001
Review
88 days
Class
Class II
Product code
DWF
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K840002 (1984). 2 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2003: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2014: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2026: 3 descendants cleared2025: 1 descendant clearedK840002 · Arterial Cannula Curved Beveled Tip · Dlp, Inc. · 1984 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K840002 · Arterial Cannula Curved Beveled Tip · Dlp, Inc. · 1984 · recalled0+5
  1. Root · 1 generation backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
  2. This deviceK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001
  3. Descendant · cites it directly · 11 of its ownK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
  4. Descendant · cites it directly · 10 of its ownK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
  6. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  7. Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12011: 12012: 12014: 22015: 12025: 12026: 3
2003high 3 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…Medtronic Perfusion Systems · 2003 · cites it directly11descendants
  • K043179Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · cites it directly10descendants
  • K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006 · 2 generations on8descendants
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K840002Arterial Cannula Curved Beveled TipDlp, Inc.19843
0 (this device)K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products2001—
+1K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…Medtronic Perfusion Systems20032
+1K043179Select 3D Arterial CannulaMedtronic Perfusion Systems20051
+2K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems2006—
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
201110
201210
201420
201510
202510
202630
FIG. 1 — Lineage of K013013, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K840002Arterial Cannula Curved Beveled Tip
Summary page 2
…21 CFR 870.4210 Predicate Substantially Equivalent Devices: Medtronic DLP Arterial Cannulae, Class Ii at 21 CFR 870.4210, Curved Tip Models cleared under 510(k) Number K840002, and 24 Fr. 3D Tip Models cleared under 510(k) Number K000776. Description of Device: The Medtronic DLP Arterial Cannulae with…
Dlp, Inc.19843
*K000776Medtronic DLP Arterial Cannulae with 3D Tip
Summary page 2
…edtronic DLP Arterial Cannulae, Class Ii at 21 CFR 870.4210, Curved Tip Models cleared under 510(k) Number K840002, and 24 Fr. 3D Tip Models cleared under 510(k) Number K000776. Description of Device: The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Ar…
Medtronic Cardiac Surgical Products20011

Also cleared against K840002: 2 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…Medtronic Perfusion Systems200311
K043179Select 3D Arterial CannulaMedtronic Perfusion Systems200510

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 30, 2014Class IIZ-0996-2014Under Investigation by firmMedtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K033416 (Medtronic Perfusion Systems, 2003) has gone furthest, with 11 descendants of its own.
  • 2 other devices also cite its predicate K840002.

How does its category compare?

All DWF devices

DWF 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

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

What is it indicated for?

These cannulae are intended for use in perfusion of the ascending

aorta during short-term (6 hours or less) cardiopulmonary bypass.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K840002

2 other devices cite the same predicate.

  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011
  • K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda…Medtronic Perfusion Systems · 20032 recalls

More from Medtronic Cardiac Surgical Products

7 FDA decisions under this applicant name. See the company

  • K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products · 20033 recalls
  • K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products · 2001
  • K010737Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 20011 recall
  • K000776Medtronic DLP Arterial Cannulae with 3D TipMedtronic Cardiac Surgical Products · 20011 recall
  • K994171Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy CannulaeMedtronic Cardiac Surgical Products · 2000

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K013013 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013013: Medtronic DLP Arterial Cannula with 3D Tip - 22 FR..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013013

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026