510(k) · Cleared
ClearedStockert S5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livanova Deutschland, GmbH · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Apr 5, 2021 as substantially equivalent to K071318 (Sorin Group Deutschland GmbH, 2007) after a 76-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 5, 2021
- Review
- 76 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971520 (1997). 5 ancestors in all, the oldest K950990 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971520 S3 Cyclic RPM ControlStoeckert Instrumente · 1997
- 2 generations backK042374 Stockert SCP RhythmStockert Instrumente GmbH · 2004
- 1 generation backK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · Recalled
- This deviceK210130 Stockert S5 SystemLivanova Deutschland, GmbH · 2021
- Descendant · cites it directly · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971520 | S3 Cyclic RPM Control | Stoeckert Instrumente | 1997 | — |
| −2 | K042374 | Stockert SCP Rhythm | Stockert Instrumente GmbH | 2004 | — |
| −1 | K071318 | Modification to: Stockert S5 System | Sorin Group Deutschland GmbH | 2007 | 13 |
| 0 (this device) | K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021 | — |
| +1 | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
| +2 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071318 | Modification to: Stockert S5 SystemSummary page 5…RMATION The modified Stockert S5 System is substantially equivalent in function and intended use to the Stockert S5 System cleared in Premarket Notification K071318. INDICATIONS FOR USE The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasti… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221373 | Essenz HLM | 2023 | 1 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K221373 (Livanova Deutschland, GmbH, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071318.
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. 2021, 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 Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210130: Stockert S5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210130
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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