510(k) · Cleared
Recalled · Class II · 2019Centrifugal Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stockert Instrumente GmbH · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Feb 5, 2002 as substantially equivalent to K991864 (Jostra Medizintechnik AG, 2000) after a 238-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 5, 2002
- Review
- 238 days
- Class
- Class II
- Product code
- DWA
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991864 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK991864 Rotaflow Centrifugal Pump SystemJostra Medizintechnik AG · 2000 · Recalled
- This deviceK011838 Centrifugal PumpStockert Instrumente GmbH · 2002
- Descendant · cites it directly · 1 of its ownK021694 Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK192838 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal…Spectrum Medical, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK032213 Stockert Centrifugal Pump System with Tubing ClampStockert Instrumente GmbH · 2003
- Descendant · 2 generations on · 0 of its ownK030141 Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K021694Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 2003 · cites it directly1descendant
- K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical, Ltd. · 2020 · cites it directly0descendants
- K032213Stockert Centrifugal Pump System with Tubing ClampStockert Instrumente GmbH · 2003 · cites it directly0descendants
- K030141Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991864 | Rotaflow Centrifugal Pump System | Jostra Medizintechnik AG | 2000 | 2 |
| 0 (this device) | K011838 | Centrifugal Pump | Stockert Instrumente GmbH | 2002 | — |
| +1 | K021694 | Cardiovention Powerbase Console, Model PBC-100 | Cardiovention, Inc. | 2003 | — |
| +1 | K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium… | Spectrum Medical, Ltd. | 2020 | — |
| +1 | K032213 | Stockert Centrifugal Pump System with Tubing Clamp | Stockert Instrumente GmbH | 2003 | — |
| +2 | K030141 | Modification to Cardiovention Powerbase Console, Model PCB-100 | Cardiovention, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2020 | 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 DWA? 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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 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 |
|---|---|---|---|
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 1…Stickert Centrifugal Pump Common/Usual Name: Centrifugal Pump Classification Name: Cardiopulmonary bypass speed control device 3. PREDICATE DEVICES » Jostra RotaFlow (K991864) » Medtronic Bio-Medicus BioConsole 540/550 (Multiple) 4, DEVICE DESCRIPTION The Stockert Centrifugal Pump, developed to addres… | 2000 |
| * | — | Medtronic Bio-Medicus BioConsole 540/550 Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2019 | Class II | Z-2440-2020 | Device Design | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle… |
| Aug 26, 2019 | Class II | Z-2439-2020 | Device Design | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle… |
| Sep 20, 2012 | Class II | Z-0166-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a… |
| Sep 20, 2012 | Class II | Z-0167-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stéckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control
device (21 CFR 870.4380) indicated for use exclusively with the COBE
Revolution Pump Head, for speed-controlled pumping through the
cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCP has been qualified only for typical durations of six hours or less,
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 heart, or extracorporeal membrane
oxygenation (ECMO) procedures.
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/K011838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011838: Centrifugal Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011838
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026