510(k) · Cleared

Cleared

Sarns Venous Return Catheters with Duraflo Treatment

K964374510(k) TraditionalCleared Jun 18, 1997229-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

3M Healthcare · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jun 18, 1997 as substantially equivalent to K905224 (3M Health Care, Sarns, 1991) and 4 other predicates after a 229-day review. Its family tree reaches back 1 generation to 1977.

Decided: Jun 18, 1997
Review: 229 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K770431 (1977). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK770431 Catheter, Two Stage Venous Return3M Health Care, Sarns · 1977 · Recalled
This deviceK964374 Sarns Venous Return Catheters with Duraflo Treatment3M Healthcare · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770431	Catheter, Two Stage Venous Return	3M Health Care, Sarns	1977	1
0 (this device)	K964374	Sarns Venous Return Catheters with Duraflo Treatment	3M Healthcare	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1981	1	0
1988	1	0
1991	1	0

FIG. 1 — Lineage of K964374, 1977–1997Source: 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? (6)

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
*	K905224	Cardiopulmonary Bypass Vascular Catheter Summary page 1 …ting Sarns Venous Return Catheters [510(k) clearance numbers listed in the table below]. Catheter Type 510(k) Number Clearance Date 20, 24, 28, and 32 French Size (Fr.) K905224 2/57/91 non-wire Venous Return Catheter sizes; 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 30, and 34 Fr. wire-reinforced Venous Retur…	3M Health Care, Sarns	1991	2
*	K875048	Sarns Venoatrial Catheter Summary page 1 …eter sizes; 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 30, and 34 Fr. wire-reinforced Venous Return Catheter sizes, Right Angle Venous Return Catheters Venoatrial Catheters K875048 2/18/88 Two Stage Venous Return Catheters K810415 3/17/81 (wire-reinforced), Dual Stage Venous Return Catheters 32, 36, and 40 F…	3M Health Care, Sarns	1988	1
*	K810415	Sarns Two-State Wire Reinforced Catheter Summary page 1 …30, and 34 Fr. wire-reinforced Venous Return Catheter sizes, Right Angle Venous Return Catheters Venoatrial Catheters K875048 2/18/88 Two Stage Venous Return Catheters K810415 3/17/81 (wire-reinforced), Dual Stage Venous Return Catheters 32, 36, and 40 Fr. wire-reinforced K790246 3/2/79 Venous Return Ca…	3M Health Care, Sarns	1981	—
*	K790246	Sarns Wire-Reinforced Venous Return Can Summary page 1 …ial Catheters K875048 2/18/88 Two Stage Venous Return Catheters K810415 3/17/81 (wire-reinforced), Dual Stage Venous Return Catheters 32, 36, and 40 Fr. wire-reinforced K790246 3/2/79 Venous Return Catheters Two Stage Venous Return Catheters (non- \| K770431 3/16/77 wire-reinforced) 32, 26, 40 and 51 Fr.…	3M Health Care, Sarns	1979	1
*	K770431	Catheter, Two Stage Venous Return Summary page 1 …ire-reinforced), Dual Stage Venous Return Catheters 32, 36, and 40 Fr. wire-reinforced K790246 3/2/79 Venous Return Catheters Two Stage Venous Return Catheters (non- \| K770431 3/16/77 wire-reinforced) 32, 26, 40 and 51 Fr. Venous Return Preamendment Catheters Page_i_iofl?i Device Descr…	3M Health Care, Sarns	1977	1
*	—	32, 26, 40 and 51 Fr. Venous Return Catheters Named without a submission number			—

Also cleared against K905224: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

4 of the 5 ancestors have a recall of any class.
1 other device also cites its predicate K905224.

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?

The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery.

The Sarns Two Stage Venous Return Catheters with Duraflo Treatment, Venoatrial Catheters with Duraflo Treatment, and the Dual Stage Venous Return Catheters with Duraflo Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardiopulmonary bypass surgery.

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

https://510kreport.com/device/K964374 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964374: Sarns Venous Return Catheters with Duraflo Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964374

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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