510(k) · Cleared
ClearedS3 Cyclic RPM Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stoeckert Instrumente · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cleared on Sep 10, 1997 after a 138-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 7 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 138 days
- Class
- Class II
- Product code
- DWB
- Recalls
- None
- Predicates
- 1
7 later devices descend from it, 2 citing it directly.
- This deviceK971520 S3 Cyclic RPM ControlStoeckert Instrumente · 1997
- Descendant · cites it directly · 6 of its ownK042374 Stockert SCP RhythmStockert Instrumente GmbH · 2004
- Descendant · cites it directly · 5 of its ownK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK210130 Stockert S5 SystemLivanova Deutschland, GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042374Stockert SCP RhythmStockert Instrumente GmbH · 2004 · cites it directly6descendants
- K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · cites it directly5descendants
- K210130Stockert S5 SystemLivanova Deutschland, GmbH · 2021 · 2 generations on2descendants
- K112225Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · 2 generations on2descendants
- K082344Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971520 | S3 Cyclic RPM Control | Stoeckert Instrumente | 1997 | — |
| +1 | K042374 | Stockert SCP Rhythm | Stockert Instrumente GmbH | 2004 | — |
| +1 | K071318 | Modification to: Stockert S5 System | Sorin Group Deutschland GmbH | 2007 | 13 |
| +2 | K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021 | — |
| +2 | K112225 | Sorin Centrifugal Pump 5 (CP5) | Sorin Group Deutschland GmbH | 2011 | 4 |
| +2 | K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | Sorin Group Deutschland GmbH | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 DWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| Kept off the family tree | K883456 | Stockert-Shiley CAPS PFC 100 S Control unit 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 2…ead pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stockert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple… |
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042374 (Stockert Instrumente GmbH, 2004) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DWB devicesDWB Pump, Blood, Cardiopulmonary Bypass, Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DWB
Too few DWB 510(k)s in any year since 2007 to give a median.
Recalls per year · DWB
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWB
1in 2025
MAUDE reports naming product code DWB, 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 | 0 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 11 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 0 | — | 0 | 63 |
| 2015 | 0 | — | 0 | 122 |
| 2016 | 1 | — | 0 | 318 |
| 2017 | 0 | — | 0 | 361 |
| 2018 | 0 | — | 0 | 258 |
| 2019 | 0 | — | 0 | 155 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 0 | — | 0 | 49 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stockert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclic rpm control of an S3 pump.
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/K971520 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971520: S3 Cyclic RPM Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971520
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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