510(k) · Cleared
Recalled · Class II · 2021Advanced 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 Aug 17, 2017 as substantially equivalent to K163531 (Terumo Cardiovascular Systems Corporation, 2017) after a 24-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it. It has been recalled 14 times.
- Decided
- Aug 17, 2017
- Review
- 24 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 7 generations to K915183 (1992). 11 ancestors in all, the oldest K871131 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 6 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 5 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 4 generations backK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- 3 generations backK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
- 2 generations backK153376 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- 1 generation backK163531 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017
- This deviceK172220 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017
- Descendant · cites it directly · 0 of its ownK221895 Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −6 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −5 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −4 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| −3 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
| −2 | K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| −1 | K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | — |
| 0 (this device) | K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K163531 | Advanced Perfusion System 1Summary page 4…Terumo® Advanced Perfusion System 1 is substantially equivalent in function and intended use to the Terumo® Advanced Perfusion System 1 cleared in Premarket Notification K163531. 19 July 2017 Page 1 of 6 Terumo Cardiovascu… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221895 | Terumo Advanced Perfusion System 1 | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2021 | Class II | Z-2350-2021 | Nonconforming Material/Component | intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas… |
| Aug 25, 2020 | Class II | Z-2961-2020 | Employee error | Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection… |
| Aug 25, 2020 | Class II | Z-2959-2020 | Employee error | Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection… |
| Aug 25, 2020 | Class II | Z-2960-2020 | Employee error | Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection… |
| Jan 10, 2020 | Class II | Z-1110-2020 | Nonconforming Material/Component | These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an… |
| Jan 10, 2020 | Class II | Z-1109-2020 | Nonconforming Material/Component | These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an… |
| Jan 10, 2020 | Class II | Z-1111-2020 | Nonconforming Material/Component | These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an… |
| Jan 10, 2020 | Class II | Z-1108-2020 | Nonconforming Material/Component | These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an… |
| Apr 18, 2019 | Class II | Z-1337-2019 | Process control | The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. |
| Oct 17, 2018 | Class II | Z-1769-2019 | Process control | An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled… |
| Sep 13, 2018 | Class II | Z-0176-2019 | Error in labeling | The service manual was not updated at the time of the release of software version 1.30. |
| Aug 28, 2018 | Class II | Z-3243-2018 | Process control | Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing… |
| Aug 28, 2018 | Class II | Z-3242-2018 | Process control | Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing… |
| Jan 19, 2018 | Class II | Z-1478-2018 | Employee error | Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation). |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K221895 (Terumo Cardiovascular Systems Corporation, 2023) has gone furthest, with 0 descendants of its own.
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. 2017, 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 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.
The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
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/K172220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172220: 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/K172220
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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