510(k) · Cleared

Cleared

Sarns Soft-Flow Aortic Cannula

K132451510(k) TraditionalCleared Feb 18, 2014196-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

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

Cleared on Feb 18, 2014 as substantially equivalent to K934127 (3M Health Care, Sarns, 1994) and 3 other predicates after a 196-day review. Its family tree reaches back 4 generations to 1984.

Decided: Feb 18, 2014
Review: 196 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K840002 (1984). 12 ancestors in all, the oldest K770429 (1977). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
3 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
2 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
1 generation backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
This deviceK132451 Sarns Soft-Flow Aortic CannulaTerumo Cardiovascular Systems Corp. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	1984	3
−3	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	1
−2	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…	Medtronic Perfusion Systems	2003	2
−1	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
0 (this device)	K132451	Sarns Soft-Flow Aortic Cannula	Terumo Cardiovascular Systems Corp.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	1	0
1989	1	0
1991	1	0
1993	1	0
1994	1	0
2001	2	0
2008	1	0

FIG. 1 — Lineage of K132451, 1984–2014Source: 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? (4)

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 1 …21. CFR 807.42 10 Classification: Class 11 Product Code: DWF Predicate Devices: SarnsTM Low Jetting Aortic Arch Cannula, K934 127 SarnSTM Xcoated Cannula, K083301 Medtronic Select 3D® Arterial Cannula, 18 Fr, K(043 179 Medtronic Select 3D® Arterial Can…	3M Health Care, Sarns	1994	41
*	K083301	X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and… Summary page 1 …Class 11 Product Code: DWF Predicate Devices: SarnsTM Low Jetting Aortic Arch Cannula, K934 127 SarnSTM Xcoated Cannula, K083301 Medtronic Select 3D® Arterial Cannula, 18 Fr, K(043 179 Medtronic Select 3D® Arterial Cannula, 24 Fr, 1(033416 Purpose of Su…	Terumo Cardiovascular Systems Corp.	2008	37
*	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
*	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial… Summary page 1 …ic Arch Cannula, K934 127 SarnSTM Xcoated Cannula, K083301 Medtronic Select 3D® Arterial Cannula, 18 Fr, K(043 179 *Medtronic Select 3D® Arterial Cannula, 24 Fr, 1(033416 Purpose of Submission: Terumno Cardiovascular Systems is submitting this Premarket Notification due to cumulative changes that h…	Medtronic Perfusion Systems	2003	2

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?

The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
12 of the 12 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. 2014, 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 device is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to six hours of use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132451: Sarns Soft-Flow Aortic Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132451

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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