510(k) · Cleared
Recalled · 2010Stockert S5 System, Stockert Electrical Venous Occluder (Evo)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Dec 17, 2008 as substantially equivalent to K071318 (Sorin Group Deutschland GmbH, 2007) and 1 other predicate after a 124-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915183 (1992). 11 ancestors in all, the oldest K871131 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 2 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 1 generation backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- This deviceK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008
- 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 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −2 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −1 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| 0 (this device) | K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | Sorin Group Deutschland GmbH | 2008 | — |
| +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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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 |
|---|---|---|---|
| * | K071318 | Modification to: Stockert S5 SystemSummary page 1…accessories Proprietary Name: St6ckert S5 System 3. PREDICATE DEVICES St6ckert S5 System (Parent device), K071318 Terumo® Advanced Perfusion System 1, K022947 4. DEVICE DESCRIPTION The St6ckert Electrical Venous Occluder is an o… | 2007 |
| * | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt…Summary page 1…Proprietary Name: St6ckert S5 System 3. PREDICATE DEVICES St6ckert S5 System (Parent device), K071318 Terumo® Advanced Perfusion System 1, K022947 4. DEVICE DESCRIPTION The St6ckert Electrical Venous Occluder is an optional accessory to and designed to be opera… | 2003 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2010 | Not classified | Z-2075-2010 | 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 6 of the 11 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 DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The modified St6ckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082344
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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