510(k) · Cleared

Cleared

Sarns Arterial Cannulae with Duraflo Treatment

K964373510(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 K934127 (3M Health Care, Sarns, 1994) 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 K770429 (1977). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK770429 Cannulae, Aortic, Arch, High Flow3M Health Care, Sarns · 1977 · Recalled
This deviceK964373 Sarns Arterial Cannulae with Duraflo Treatment3M Healthcare · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770429	Cannulae, Aortic, Arch, High Flow	3M Health Care, Sarns	1977	12
0 (this device)	K964373	Sarns Arterial Cannulae with Duraflo Treatment	3M Healthcare	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	1	0
1984	1	0
1988	1	0
1994	1	0

FIG. 1 — Lineage of K964373, 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
*	K934127	Sarns Low Jetting Aortic Arch Cannula Summary page 4 …tially equivalent to the existing Sarns Arterial Cannulae [510(k) clearance numbers listed in the table below]. Cannula Type \| 510(k) Number l Clearance Date Soft Flow K934127 2/22/94 D4 K874896 2/2/88 Soft-Arc K834134 4/17/84 Flexible Arterial K771499 8/16/77 High Flow Aortic Arch K770429 3/16/77 Aorti…	3M Health Care, Sarns	1994	41
*	K874896	Sarns Visiflow Aortic Arch Cannula Summary page 4 …the existing Sarns Arterial Cannulae [510(k) clearance numbers listed in the table below]. Cannula Type \| 510(k) Number l Clearance Date Soft Flow K934127 2/22/94 D4 K874896 2/2/88 Soft-Arc K834134 4/17/84 Flexible Arterial K771499 8/16/77 High Flow Aortic Arch K770429 3/16/77 Aortic Arch, Flexible Aor…	3M Health Care, Sarns	1988	1
*	K834134	Sarns 8.0 Soft Arc Cannula Summary page 4 …erial Cannulae [510(k) clearance numbers listed in the table below]. Cannula Type \| 510(k) Number l Clearance Date Soft Flow K934127 2/22/94 D4 K874896 2/2/88 Soft-Arc K834134 4/17/84 Flexible Arterial K771499 8/16/77 High Flow Aortic Arch K770429 3/16/77 Aortic Arch, Flexible Aortic Arch Preamendment D…	3M Health Care, Sarns	1984	1
*	K771499	Flexible Arterial Cannulae Summary page 4 …umbers listed in the table below]. Cannula Type \| 510(k) Number l Clearance Date Soft Flow K934127 2/22/94 D4 K874896 2/2/88 Soft-Arc K834134 4/17/84 Flexible Arterial K771499 8/16/77 High Flow Aortic Arch K770429 3/16/77 Aortic Arch, Flexible Aortic Arch Preamendment Device Description: The only diffe…	3M Health Care, Sarns	1977	12
*	K770429	Cannulae, Aortic, Arch, High Flow Summary page 4 …nnula Type \| 510(k) Number l Clearance Date Soft Flow K934127 2/22/94 D4 K874896 2/2/88 Soft-Arc K834134 4/17/84 Flexible Arterial K771499 8/16/77 High Flow Aortic Arch K770429 3/16/77 Aortic Arch, Flexible Aortic Arch Preamendment Device Description: The only difference between the Sarns Arterial Cannu…	3M Health Care, Sarns	1977	12
*	—	Sarns Aortic Arch and Flexible Aortic Arch Cannulae Named without a submission number			—

Also cleared against K934127: 4 other devices →

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?

5 of the 5 ancestors have a recall of any class.
4 other devices also cite its predicate K934127.

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 Aortic Arch Cannulae with Duraflo Treatment, Flexible Arterial Cannulae with Duraflo Treatment, High Flow Aortic Arch Cannulae with Duraflo Treatment, Soft Arc Cannula with Duraflo Treatment, D4 Cannulae with Duraflo Treatment, and the Soft Flow Cannulae with Duraflo Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

The Sarns Flexible Aortic Arch Cannula with Duraflo Treatment is indicated for use in perfusion of the descending thoracic aorta 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/K964373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964373: Sarns Arterial Cannulae with Duraflo Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964373

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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