510(k) · Cleared
ClearedTerumo 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 · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Apr 18, 2023 as substantially equivalent to K172220 (Terumo Cardiovascular Systems Corporation, 2017) after a 292-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Apr 18, 2023
- Review
- 292 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K915183 (1992). 12 ancestors in all, the oldest K871131 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 7 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 6 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 5 generations backK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- 4 generations backK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
- 3 generations backK153376 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- 2 generations backK163531 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017
- 1 generation backK172220 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017 · Recalled
- This deviceK221895 Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −7 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −6 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −5 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| −4 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
| −3 | K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| −2 | K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | — |
| −1 | K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | 14 |
| 0 (this device) | K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023 | — |
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 DTQ? 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 DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K172220 | Advanced Perfusion System 1Summary page 4…220 Product Code: DTQ Device Classification II III. Predicate Device Substantial equivalence is claimed to: x Advanced Perfusion System 1, K172220, Terumo Cardiovascular Systems Corporation IV. Device Description The Terumo® Advanced Perfusion System 1 (System 1) is a co… | 2017 |
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 31 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 6 of the 12 ancestors have a recall of any class.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, 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 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Terumo® Advanced Perfusion System 1 is indicated for use for up to six 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.
The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221895: Terumo Advanced Perfusion System 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221895
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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