510(k) · Cleared
ClearedStockert Centrifugal Pump Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stockert Instrumente GmbH · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Sep 23, 2002 as substantially equivalent to K991864 (Jostra Medizintechnik AG, 2000) and 2 other predicates after a 214-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Sep 23, 2002
- Review
- 214 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K920077 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920077 | Nikkiso NK Pump | International Medical Products, Inc. | 1993 | — |
| −1 | K972740 | Himex Centriflow Centrifugal Perfusion Pump System (CFK01) | Himex Production Corp. | 1998 | — |
| 0 (this device) | K020571 | Stockert Centrifugal Pump Console | Stockert Instrumente GmbH | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K991864 | Rotaflow Centrifugal Pump System | 2000 |
| * | K972740 | Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Summary page 1…edtronic Bio-Console 540/550 (Multiple) 0 RotaFlow Centrifugal Pump System (E99 1864) 0 Himex Centriflow Centrifugal Perfision Pump System (K972740) 0 Stockert Compact System (K982014) ~~ ~~ Stockert Instrumente GmbH 5 1O(k)… | 1998 |
| * | K982014 | Stockert Compact SystemSummary page 1…0 RotaFlow Centrifugal Pump System (E99 1864) 0 Himex Centriflow Centrifugal Perfision Pump System (K972740) 0 Stockert Compact System (K982014) ~~ ~~ Stockert Instrumente GmbH 5 1O(k) July 9, 2002 Stockert Centrifugal… | 1998 |
| * | — | Medtronic Bio-Console 540/550 Named without a submission number |
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 9 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 8 other devices also cite its predicate K991864.
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 Stockert Centrifugal Pump Console (SCPC System) is a sofhvare-controlled cardiopulmonary bypass device containing an unintermptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stockert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass…
Read the full statement (120 words)
The Stockert Centrifugal Pump Console (SCPC System) is a sofhvare-controlled cardiopulmonary bypass device containing an unintermptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stockert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural head, or extracorporeal membrane oxygenation (ECMO) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020571: Stockert Centrifugal Pump Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020571
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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