510(k) Report

510(k) · Cleared

Cleared

Eopa Elongated One-Piece Arterial Cannula with Guidewire

K000274510(k) SpecialCleared Feb 10, 200010-day reviewClass II21 CFR 870.4210

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 Feb 10, 2000 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Feb 10, 2000
Review
10 days
Class
Class II
Product code
DWF
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2025: 2 descendants cleared2015: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK000274 Eopa Elongated One-Piece Arterial Cannula with GuidewireMedtronic Cardiac Surgical Products · 2000
  2. Descendant · cites it directly · 11 of its ownK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · Recalled
  3. Descendant · 2 generations on · 6 of its ownK031518 Eopa Cap Elongated One-Piece Arterial Cannula with Pressure…Medtronic Vascular · 2003
  4. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  5. Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 3 of its ownK110980 Centrimag Return Cannula KitLevitronix, LLC · 2011

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 22009: 12011: 22012: 12014: 12015: 12020: 12024: 12025: 22026: 2
2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 14 · See all
  • K031037Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · cites it directly11descendants
  • K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…Medtronic Vascular · 2003 · 2 generations on6descendants
  • 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
  • K110980Centrimag Return Cannula KitLevitronix, LLC · 2011 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000274Eopa Elongated One-Piece Arterial Cannula with GuidewireMedtronic Cardiac Surgical Products2000—
+1K031037Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems20036
+2K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line…Medtronic Vascular2003—
+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
+2K110980Centrimag Return Cannula KitLevitronix, LLC2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200910
201120
201210
201410
201510
202010
202410
202520
202620
FIG. 1 — Lineage of K000274, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K031037Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems200311
K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091

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?

  • Of its descendants, K031037 (Medtronic Perfusion Systems, 2003) has gone furthest, with 11 descendants of its own.

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—

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
  • K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 20011 recall
  • 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

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/K000274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000274: Eopa Elongated One-Piece Arterial Cannula with Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000274

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026