510(k) · Cleared

Cleared

Venous Return Cannulae

K250937510(k) TraditionalCleared Mar 11, 2026348-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

LivaNova USA, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 11, 2026 as substantially equivalent to K943934 (Sorin Group Italia S.R.L., 1995) and 4 other predicates after a 348-day review. Its family tree reaches back 7 generations to 1984. 1 of the 82 devices in its family, counting itself, has a Class I recall.

Decided: Mar 11, 2026
Review: 348 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K840002 (1984). 81 ancestors in all, the oldest K790563 (1979). No later device cites it as a predicate yet. 1 of the 82 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 7 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
6 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
5 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
4 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
3 generations backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
2 generations backK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
1 generation backK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
This deviceK250937 Venous Return CannulaeLivaNova USA, Inc. · 2026

Class I recalls in this family

K834039 Infant Vent Catheter 12001 W/Side Vent3 generations back · 1984

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	1984	3
−6	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	1
−5	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…	Medtronic Perfusion Systems	2003	2
−4	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
−3	K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222	Medtronic Perfusion Systems	2006	—
−2	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
−1	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
0 (this device)	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
1986	1	0
1987	2	0
1988	3	0
1989	2	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	6	0
2001	7	0
2002	2	0
2003	8	0
2005	3	0
2007	1	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K250937, 1984–2026Source: 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.

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

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What was it cleared against? (5)

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
*	K943934	Aortic Arch Cannulas Summary page 5 …Both subject and predicate devices have the same fundamental scientific technology and intended use: 510(k) Number: K943934 Device Trade Name: Venous Return Cannulae Classification Name:…	Sorin Group Italia S.R.L.	1995	4
*	K890980	Modified Stockert-Shiley Venous Catheter Summary page 5 …Classification: Class II Classification Panel: Cardiovascular 510(k) Number: K890980 Device Trade Name: Modified Stockert_Shiley Venous…	Shiley, Inc.	1989	—
*	K861496	Stockert-Shiley Venous Cath & Aortic Arch Cannula Summary page 6 …nal 510(k) – Venous Return Cannulae Page 1 510(k) Number: K861496 Device Trade Name: Stockert_Shiley Venous Catheter Classificat…	Shiley, Inc.	1986	—
*	K994209	Stockert V142 Series Venous Cannulae with Lighthouse Tip Summary page 6 …Classification: Class II Classification Panel: Cardiovascular 510(k) Number: K994209 Device Trade Name: Stockert V142 Series Venous Cannulae Classi…	Cobe Cardiovascular, Inc.	2000	—
*	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single… Summary page 6 …Classification: Class II Classification Panel: Cardiovascular 510(k) Number: K120988 Device Trade Name: DLP Single stage venous cannula…	Medtronic, Inc.	2012	2

Also cleared against K943934: 3 other devices →

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 · 3 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 1.9 years on median.
33 of the 81 ancestors have a recall of any class; 1 has a Class I recall.
3 other devices also cite its predicate K943934.

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. 2026, this device’s year, is highlighted.

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?

The Venous Return Cannula is indicated for use in drainage of the superior and inferior vena cava during cardiopulmonary bypass surgery for up to six hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K250937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250937: Venous Return Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250937

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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