510(k) · Cleared
Cleared3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Nov 17, 1995 after a 273-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 31 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it.
- Decided
- Nov 17, 1995
- Review
- 273 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly. 3 of the 31 devices in this family, counting this one, have a Class I recall.
- This deviceK950739 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900…3M Health Care, Sarns · 1995
- Descendant · cites it directly · 26 of its ownK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- Descendant · 2 generations on · 6 of its ownK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · 3 generations on · 5 of its ownK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K022947Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Terumo Cardiovascular Systems Corp. · 2003 · cites it directly26descendants
- K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · 2 generations on8descendants
- K131041Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014 · 2 generations on6descendants
- K070286Bio-Console, Model 560Medtronic · 2007 · 2 generations on6descendants
- K151349Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion… | 3M Health Care, Sarns | 1995 | — |
| +1 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| +2 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| +2 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| +2 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +3 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2013 | 2 | 1 |
| 2014 | 3 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. 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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022947 (Terumo Cardiovascular Systems Corp., 2003) has gone furthest, with 26 descendants of its own.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950739: 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950739
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026