510(k) · Cleared

Recalled · Class II · 2014

Three Stage Venous Return Cannula, Model 816460

K080034510(k) TraditionalCleared Jun 17, 2008162-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

Terumo Cardiovascular Systems Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jun 17, 2008 as substantially equivalent to K810415 (3M Health Care, Sarns, 1981) after a 162-day review. Its family tree reaches back 1 generation to 1981. It has been recalled once.

Decided: Jun 17, 2008
Review: 162 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K810415 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK810415 Sarns Two-State Wire Reinforced Catheter3M Health Care, Sarns · 1981
This deviceK080034 Three Stage Venous Return Cannula, Model 816460Terumo Cardiovascular Systems Corp. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K810415	Sarns Two-State Wire Reinforced Catheter	3M Health Care, Sarns	1981	—
0 (this device)	K080034	Three Stage Venous Return Cannula, Model 816460	Terumo Cardiovascular Systems Corp.	2008	—

FIG. 1 — Lineage of K080034, 1981–2008Source: 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

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What was it cleared against? (1)

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
*	K810415	Sarns Two-State Wire Reinforced Catheter Summary page 2 …1 CFR § 870.4210. Predicate Device The unmodified predicate device is identified as Terumo's current line of Dual Stage Venous Return Cannulae, which fall under 510(k) # K810415. Device Description The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for conn…	3M Health Care, Sarns	1981	—

Also cleared against K810415: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 23, 2014	Class II	Z-2104-2014	Process control	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K810415.

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. 2008, 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?

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080034 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080034: Three Stage Venous Return Cannula, Model 816460.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080034

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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