510(k) · Cleared

Cleared

Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models 774XX, 775XX, 776XX, 777XX, 788XX,

K031518510(k) SpecialCleared May 22, 20037-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 Vascular · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on May 22, 2003 as substantially equivalent to K031037 (Medtronic Perfusion Systems, 2003) and 1 other predicate after a 7-day review. Its family tree reaches back 3 generations to 1988. 6 later devices descend from it.

Decided: May 22, 2003
Review: 7 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K880421 (1988). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK880421 Descending Arch CannulaDlp, Inc. · 1988
2 generations backK991066 Madtronic DLP Arterial CannulaeMedtronic Vascular · 1999
1 generation backK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · Recalled
This deviceK031518 Eopa Cap Elongated One-Piece Arterial Cannula with Pressure…Medtronic Vascular · 2003
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all

K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K880421	Descending Arch Cannula	Dlp, Inc.	1988	—
−2	K991066	Madtronic DLP Arterial Cannulae	Medtronic Vascular	1999	—
−1	K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	2003	6
0 (this device)	K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line…	Medtronic Vascular	2003	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+3	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+4	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—
+5	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
1989	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K031518, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	2003	6
*	K010737	Select Cap Arterial Cannula with Pressure Monitoring Line, Model…	Medtronic Cardiac Surgical Products	2001	1

Also cleared against K031037: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5

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?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
3 of the 6 ancestors have a recall of any class.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K031037.

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

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

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

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

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 use with cardiopulmonary bypass as an arterial return cannula.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031518: Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models 774XX, 775XX, 776XX, 777XX, 788XX,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031518

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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