510(k) · Cleared
ClearedAdvanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cleared on Dec 19, 2011 as substantially equivalent to K953901 (3M Health Care, Sarns, 1996) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it.
- Decided
- Dec 19, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- DWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915183 (1992). 4 ancestors in all, the oldest K871131 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 1 generation backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- This deviceK112587 Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump…Terumo Cardiovascular Systems Corp. · 2011
- Descendant · cites it directly · 6 of its ownK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- Descendant · 2 generations on · 5 of its ownK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
- Descendant · 3 generations on · 4 of its ownK153376 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 2 of its ownK163531 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017
- Descendant · 5 generations on · 1 of its ownK172220 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131041Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014 · cites it directly6descendants
- K151349Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · 2 generations on5descendants
- K153376Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · 3 generations on4descendants
- K163531Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017 · 4 generations on2descendants
- K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −1 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| 0 (this device) | K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch… | Terumo Cardiovascular Systems Corp. | 2011 | — |
| +1 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| +2 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +3 | K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| +4 | K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | — |
| +5 | K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | 14 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K953901 | Sarns 800 Roller PumpSummary page 1…21 CFR § 870.4370 Product Code(s) DWB Legally marketed device(s) to which SarnS TM 8000 Roller Pump (K953901) equivalence is claimed Sarns TM 9000 Universal Roller Pump… | 1996 |
| * | K953904 | Sarns 9000 Universal Roller PumpSummary page 1…nS TM 8000 Roller Pump (K953901) equivalence is claimed Sarns TM 9000 Universal Roller Pump (K953904) Reason for 510(k) submission 6" Large Roller pump for the APSi… | 1996 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K131041 (Terumo Cardiovascular Systems Corp., 2014) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K953901.
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. 2011, 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 Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is 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 as stated in the FDA summary.
https://510kreport.com/device/K112587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112587
Report an extraction error
Are you the manufacturer?
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