510(k) · Cleared
Recalled · Class II · 2015Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Mar 20, 2003 as substantially equivalent to K871131 (3M Health Care, Sarns, 1987) and 4 other predicates after a 196-day review. Its family tree reaches back 2 generations to 1992. 3 of the 32 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled 150 times.
- Decided
- Mar 20, 2003
- Review
- 196 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 150
- Predicates
- 6
Its longest line of descent runs back 2 generations to K915183 (1992). 5 ancestors in all, the oldest K871131 (1987). 26 later devices descend from it, 6 citing it directly. 3 of the 32 devices in this family, counting this one, have a Class I recall.
- 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 deviceK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003
- Descendant · cites it directly · 8 of its ownK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- Descendant · cites it directly · 6 of its ownK131041 Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
- Descendant · cites it directly · 6 of its ownK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · 2 generations on · 5 of its ownK151349 Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015
- Descendant · 2 generations on · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
2006high 5 (2023) · low 0 (2012)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · cites it directly8descendants
- K131041Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014 · cites it directly6descendants
- K070286Bio-Console, Model 560Medtronic · 2007 · cites it directly6descendants
- K151349Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2015 · 2 generations on5descendants
- K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · 2 generations on5descendants
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) | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | — |
| +1 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| +1 | K131041 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| +1 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +2 | K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +2 | K090006 | Lifebridge B2T, Model 7001 | Lifebridge Medizintechnik AG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K871131 | Sarns 9000 Heart-Lung ConsoleSummary page 1…Device Classification Name: Cardiopulmonary bypass heart-lung machine (21 CFR 870.4220) Predicate Devices: SarnsTM9000Heart-Lung Console (K871131) SarnsTM8000 Modular Perfusion System (K915183) SarnsTM8000 Roller Pump (K953901) SarnsTM9000 Unive… | 1987 |
| * | K915183 | Sarns 8000 Modular Perfusion SystemSummary page 1…pass heart-lung machine (21 CFR 870.4220) Predicate Devices: SarnsTM9000Heart-Lung Console (K871131) SarnsTM8000 Modular Perfusion System (K915183) SarnsTM8000 Roller Pump (K953901) SarnsTM9000 Universal Roller Pump (K953904) Flow Sensor Centrifu… | 1992 |
| * | K953901 | Sarns 800 Roller PumpSummary page 1…Predicate Devices: SarnsTM9000Heart-Lung Console (K871131) SarnsTM8000 Modular Perfusion System (K915183) SarnsTM8000 Roller Pump (K953901) SarnsTM9000 Universal Roller Pump (K953904) Flow Sensor Centrifugal Control Module (K950739) Delph… | 1996 |
| * | K953904 | Sarns 9000 Universal Roller PumpSummary page 1…-Lung Console (K871131) SarnsTM8000 Modular Perfusion System (K915183) SarnsTM8000 Roller Pump (K953901) SarnsTM9000 Universal Roller Pump (K953904) Flow Sensor Centrifugal Control Module (K950739) Delphin II/Stand-Alone Centrifugal Module (K935978)… | 1996 |
| * | K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemSummary page 1…sion System (K915183) SarnsTM8000 Roller Pump (K953901) SarnsTM9000 Universal Roller Pump (K953904) Flow Sensor Centrifugal Control Module (K950739) Delphin II/Stand-Alone Centrifugal Module (K935978) Indication for Use The TerumoB Advanced Perfu… | 1995 |
| Kept off the family tree | K935978 | Delphin II/Stand-Alone Centrifugal Module Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…01) SarnsTM9000 Universal Roller Pump (K953904) Flow Sensor Centrifugal Control Module (K950739) Delphin II/Stand-Alone Centrifugal Module (K935978) Indication for Use The TerumoB Advanced Perfusion System 1 is indicated for up to 6 hours of use in… |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052555 | Medtronic Performer TM CPB, Model R51, PCPB | 2006 | 8 |
| K131041 | Advanced Perfusion System 1 | 2014 | 6 |
| K070286 | Bio-Console, Model 560 | 2007 | 6 |
| K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | 2008 | 2 |
| K070213 | Performer CBP System | 2007 | 1 |
| K080832 | Stockert S5 System, Stockert Gas Blender | 2008 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2015 | Class II | Z-1687-2015 | Device Design | Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: -… |
| May 1, 2015 | Class II | Z-1688-2015 | Device Design | Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: -… |
| Jun 17, 2014 | Class II | Z-2019-2014 | Labeling Change Control | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. |
| Jun 17, 2014 | Class II | Z-2018-2014 | Labeling Change Control | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. |
| Jul 26, 2013 | Class II | Z-1974-2013 | Device Design | Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement… |
| Jul 26, 2013 | Class II | Z-1969-2013 | Software design | The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control… |
| Jul 26, 2013 | Class II | Z-1978-2013 | Software design | TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that… |
| Jul 26, 2013 | Class II | Z-1973-2013 | Device Design | Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement… |
| Jul 26, 2013 | Class II | Z-1968-2013 | Software design | The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control… |
| Jul 26, 2013 | Class II | Z-1977-2013 | Software design | TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that… |
| Nov 14, 2012 | Class II | Z-0435-2013 | Device Design | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and… |
| Nov 14, 2012 | Class II | Z-0436-2013 | Device Design | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and… |
| Sep 20, 2012 | Class II | Z-2449-2012 | Process control | Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on… |
| Sep 10, 2012 | Class II | Z-2443-2012 | Release of Material/Component prior to receiving test results | Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a… |
| Jul 26, 2012 | Class II | Z-2177-2012 | Component design/selection | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo… |
| Jul 26, 2012 | Class II | Z-2178-2012 | Component design/selection | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo… |
| Jul 26, 2012 | Class II | Z-2233-2012 | Device Design | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the… |
| Jul 26, 2012 | Class II | Z-2232-2012 | Device Design | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the… |
| Jul 26, 2012 | Class II | Z-2231-2012 | Device Design | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the… |
| Jul 26, 2012 | Class II | Z-2230-2012 | Device Design | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the… |
| Jun 25, 2012 | Class II | Z-1969-2012 | Equipment maintenance | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion… |
| Jun 25, 2012 | Class II | Z-1971-2012 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with… |
| Jun 25, 2012 | Class II | Z-1970-2012 | Device Design | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with… |
| Jun 25, 2012 | Class II | Z-1968-2012 | Equipment maintenance | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion… |
| Jun 22, 2012 | Class II | Z-1962-2012 | Error in labeling | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local… |
| Jun 22, 2012 | Class II | Z-2055-2012 | Equipment maintenance | Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System… |
| Jun 22, 2012 | Class II | Z-1958-2012 | Device Design | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss… |
| Jun 22, 2012 | Class II | Z-2056-2012 | Equipment maintenance | Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System… |
| Jun 22, 2012 | Class II | Z-1957-2012 | Device Design | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss… |
| Jun 22, 2012 | Class II | Z-1966-2012 | Device Design | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to… |
| Jun 22, 2012 | Class II | Z-1963-2012 | Error in labeling | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local… |
| Jun 22, 2012 | Class II | Z-1965-2012 | Device Design | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to… |
| Jun 22, 2012 | Class II | Z-1964-2012 | Error in labeling | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local… |
| Jun 21, 2012 | Class II | Z-2021-2012 | Process control | Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has… |
| Jun 21, 2012 | Class II | Z-2020-2012 | Process control | Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has… |
| Jun 21, 2012 | Class II | Z-2010-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module… |
| Jun 21, 2012 | Class II | Z-2009-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module… |
| Jun 18, 2012 | Class II | Z-2042-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes… |
| Jun 18, 2012 | Class II | Z-2043-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes… |
| Mar 16, 2012 | Not classified | Z-1320-2012 | Device Design | Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although… |
| Mar 16, 2012 | Not classified | Z-1321-2012 | Device Design | Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although… |
| Jan 13, 2012 | Not classified | Z-0839-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo… |
| Jan 13, 2012 | Not classified | Z-0840-2012 | Nonconforming Material/Component | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo… |
| Nov 10, 2011 | Not classified | Z-0301-2012 | Nonconforming Material/Component | Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt… |
| Nov 10, 2011 | Not classified | Z-0302-2012 | Nonconforming Material/Component | Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt… |
| Nov 10, 2011 | Not classified | Z-0300-2012 | Nonconforming Material/Component | Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt… |
| Nov 8, 2011 | Not classified | Z-0299-2012 | Component design/selection | 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12)… |
| Nov 8, 2011 | Not classified | Z-0298-2012 | Component design/selection | 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12)… |
| May 3, 2011 | Not classified | Z-2613-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
| May 3, 2011 | Not classified | Z-2620-2011 | Other | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's… |
The 5 latest of 50 recalls; the web page lists all.
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K052555 (Rand S.R.L., 2006) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K871131.
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.
FDA decisions per year · DTQ
3in 2023
2007high 3 (2009) · low 0 (2012)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
2007high 292 (2023) · low 86 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
2007high 42 (2012) · low 0 (2015)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
2007high 1,626 (2012) · low 420 (2007)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 TerumoB 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 as stated in the FDA summary.
https://510kreport.com/device/K022947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022947
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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