510(k) · Cleared
ClearedSarns High Flow Aortic Arch Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Feb 3, 2014 as substantially equivalent to K770429 (3M Health Care, Sarns, 1977) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Feb 3, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K770429 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK770429 Cannulae, Aortic, Arch, High Flow3M Health Care, Sarns · 1977 · Recalled
- 1 generation backK083301 X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns…Terumo Cardiovascular Systems Corp. · 2008 · Recalled
- This deviceK133151 Sarns High Flow Aortic Arch CannulaTerumo Cardiovascular Systems Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770429 | Cannulae, Aortic, Arch, High Flow | 3M Health Care, Sarns | 1977 | 12 |
| −1 | K083301 | X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable… | Terumo Cardiovascular Systems Corp. | 2008 | 37 |
| 0 (this device) | K133151 | Sarns High Flow Aortic Arch Cannula | Terumo Cardiovascular Systems Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
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 14.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K770429 | Cannulae, Aortic, Arch, High FlowSummary page 1…R 807.42 10 Classification: Class 11 Product Code: DWF Predicate Devices: *SarnsrM High Flow Aortic Arch Cannula, K770429 *SarnSTM X-coated Aortic Cannula, K083301 Purpose of Submission: Terumo Cardiovascular Systems is submitting this Premarket No… | 1977 |
| * | 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: *SarnsrM High Flow Aortic Arch Cannula, K770429 *SarnSTM X-coated Aortic Cannula, K083301 Purpose of Submission: Terumo Cardiovascular Systems is submitting this Premarket Notification due to cumulative changes that ha… | 2008 |
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 37 years and passes through 2 companies; a new generation was cleared every 31.8 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K770429.
How does its category compare?
All DWF devicesDWF 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 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/K133151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133151: Sarns High Flow Aortic Arch Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133151
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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