510(k) · Cleared
Recalled · 2007Performer CBP System
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 21, 2007 as substantially equivalent to K052555 (Rand S.R.L., 2006) and 3 other predicates after a 58-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 21, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K915183 (1992). 9 ancestors in all, the oldest K871131 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 3 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 2 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 1 generation backK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- This deviceK070213 Performer CBP SystemRand S.R.L. · 2007
- Descendant · cites it directly · 0 of its ownK150530 Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150530Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −3 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −2 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −1 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| 0 (this device) | K070213 | Performer CBP System | Rand S.R.L. | 2007 | — |
| +1 | K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (4)
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 |
|---|---|---|---|
| * | K052555 | Medtronic Performer TM CPB, Model R51, PCPBSummary page 1…4220 FDA Classification Panel Cardiovascular Predicate Devices: *Medtronic Performer CPB Advanced Extracoporeal Circulatory Support System (K(052555) *COBB Century Precision Blood Pump (K960974) *Terumo Advanced Perfusion System 1 (K022947) *RMR Automatic Tubi… | 2006 |
| * | K960974 | Cobe Century Perfusion PumpSummary page 1…lar Predicate Devices: *Medtronic Performer CPB Advanced Extracoporeal Circulatory Support System (K(052555) *COBB Century Precision Blood Pump (K960974) *Terumo Advanced Perfusion System 1 (K022947) *RMR Automatic Tubing Clamp System (K(961364) Device Description… | 1997 |
| * | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Summary page 1…mer CPB Advanced Extracoporeal Circulatory Support System (K(052555) *COBB Century Precision Blood Pump (K960974) *Terumo Advanced Perfusion System 1 (K022947) *RMR Automatic Tubing Clamp System (K(961364) Device Description:… | 2003 |
| * | K961364 | Automatic Tubing Clamp System (Atc)Summary page 1…stem (K(052555) *COBB Century Precision Blood Pump (K960974) *Terumo Advanced Perfusion System 1 (K022947) *RMR Automatic Tubing Clamp System (K(961364) Device Description: Page 68 of 71 === Pa… | 1996 |
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 |
|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | 2015 | 0 |
Has anything in its family been recalled? (0 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)) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K150530 (Medtronic, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052555.
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. 2007, 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 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 extracorporcal 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/K070213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070213: Performer CBP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070213
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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