510(k) · Cleared
ClearedSmall (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cleared on Nov 17, 2016 as substantially equivalent to K153376 (Terumo Cardiovascular Systems Corporation, 2015) after a 37-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Nov 17, 2016
- Review
- 37 days
- Class
- Class II
- Product code
- DWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915183 (1992). 10 ancestors in all, the oldest K871131 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 5 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 4 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 3 generations backK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- 2 generations backK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
- 1 generation backK153376 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- This deviceK162843 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1…Terumo Cardiovascular Systems Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −5 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −4 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −3 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| −2 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
| −1 | K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| 0 (this device) | K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6)… | Terumo Cardiovascular Systems Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2011 | 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 DWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K153376 | Advanced Perfusion System 1Summary page 4…21 CFR §870.4370 Product Code(s) DWB Legally marketed device(s) to Terumo® Advanced Perfusion System 1: K153376 which equivalence is claimed October 7, 2016 Page 1 of 14 === P… | 2015 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K153376.
How does its category compare?
All DWB devicesDWB Pump, Blood, Cardiopulmonary Bypass, Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DWB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DWB
Too few DWB 510(k)s in any year since 2007 to give a median.
Recalls per year · DWB
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWB
1in 2025
MAUDE reports naming product code DWB, 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 | 0 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 11 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 0 | — | 0 | 63 |
| 2015 | 0 | — | 0 | 122 |
| 2016 | 1 | — | 0 | 318 |
| 2017 | 0 | — | 0 | 361 |
| 2018 | 0 | — | 0 | 258 |
| 2019 | 0 | — | 0 | 155 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 0 | — | 0 | 49 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Small (4”) and Large (6”) Roller Pumps of the Terumo® Advanced Perfusion System 1 are indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
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/K162843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162843: Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162843
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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