510(k) · Cleared
Recalled · 2010Modification to Stockert S5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Sep 28, 2006 after a 43-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 28, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK062396 Modification to Stockert S5 SystemSorin Group Deutschland GmbH · 2006
- 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
- Descendant · 3 generations on · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K221373Essenz HLMLivanova Deutschland, GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062396 | Modification to Stockert S5 System | Sorin Group Deutschland GmbH | 2006 | — |
| +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 |
| +3 | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | — | Stöckert S5 System Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071318 | Modification to: Stockert S5 System | 2007 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2010 | Not classified | Z-2073-2010 | PMA | Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071318 (Sorin Group Deutschland GmbH, 2007) has gone furthest, with 5 descendants of its own.
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 Stbckert 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/K062396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062396: Modification to 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/K062396
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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