510(k) · Cleared
Recalled · 2007Medtronic Performer TM CPB, Model R51, PCPB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rand S.R.L. · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Mar 15, 2006 as substantially equivalent to K960974 (Cobe Cardiovascular, Inc., 1997) and 1 other predicate after a 180-day review. Its family tree reaches back 3 generations to 1992. 2 of the 16 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Mar 15, 2006
- Review
- 180 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915183 (1992). 7 ancestors in all, the oldest K871131 (1987). 8 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 2 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 1 generation backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- This deviceK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006
- Descendant · cites it directly · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK070213 Performer CBP SystemRand S.R.L. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK150530 Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · cites it directly5descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
- K070213Performer CBP SystemRand S.R.L. · 2007 · cites it directly1descendant
- K150530Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015 · 2 generations on0descendants
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −2 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −1 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| 0 (this device) | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | — |
| +1 | K090006 | Lifebridge B2T, Model 7001 | Lifebridge Medizintechnik AG | 2009 | — |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +1 | K070213 | Performer CBP System | Rand S.R.L. | 2007 | 1 |
| +2 | K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015 | — |
| +3 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 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.
2 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? (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 |
|---|---|---|---|
| * | K960974 | Cobe Century Perfusion PumpSummary page 1…FDA Regulation Number 21 CTR 870.4220 FDA Classification Panel Cardiovascular Predicate Devices: *COBF Century Perfusion Punmp (K960974) *TFerUno Advanced Perflusioii System I (K022947) The Performer CPR has incorporated capabilities from five stand… | 1997 |
| * | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Summary page 1…DA Classification Panel Cardiovascular Predicate Devices: *COBF Century Perfusion Punmp (K960974) *TFerUno Advanced Perflusioii System I (K022947) The Performer CPR has incorporated capabilities from five stand alone Medtronic devices which are: *Medtroni… | 2003 |
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? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2007 | Not classified | Z-1090-2007 | Other | Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB)) |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K090006 (Lifebridge Medizintechnik AG, 2009) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K960974.
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
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 Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for 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 pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052555: Medtronic Performer TM CPB, Model R51, PCPB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052555
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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