510(k) · Cleared
Recalled · Class II · 2019Modification 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 Jul 6, 2007 as substantially equivalent to K062396 (Sorin Group Deutschland GmbH, 2006) and 3 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it. It has been recalled 13 times.
- Decided
- Jul 6, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 13
- Predicates
- 4
Its longest line of descent runs back 2 generations to K971520 (1997). 4 ancestors in all, the oldest K950990 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971520 S3 Cyclic RPM ControlStoeckert Instrumente · 1997
- 1 generation backK042374 Stockert SCP RhythmStockert Instrumente GmbH · 2004
- This deviceK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007
- Descendant · cites it directly · 2 of its ownK210130 Stockert S5 SystemLivanova Deutschland, GmbH · 2021
- Descendant · cites it directly · 2 of its ownK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K210130Stockert S5 SystemLivanova Deutschland, GmbH · 2021 · cites it directly2descendants
- K112225Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · cites it directly2descendants
- K082344Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · cites it directly2descendants
- K221373Essenz HLMLivanova Deutschland, GmbH · 2023 · 2 generations on1descendant
- K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971520 | S3 Cyclic RPM Control | Stoeckert Instrumente | 1997 | — |
| −1 | K042374 | Stockert SCP Rhythm | Stockert Instrumente GmbH | 2004 | — |
| 0 (this device) | K071318 | Modification to: Stockert S5 System | Sorin Group Deutschland GmbH | 2007 | — |
| +1 | K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021 | — |
| +1 | K112225 | Sorin Centrifugal Pump 5 (CP5) | Sorin Group Deutschland GmbH | 2011 | 4 |
| +1 | K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | Sorin Group Deutschland GmbH | 2008 | 1 |
| +2 | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
| +3 | 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 |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K062396 | Modification to Stockert S5 SystemSummary page 1…fication Name: Cardiopulmonary bypass heart-lung machine console and accessories 3. PREDICATE DEVICES • St6ckert S5 System (K062396) * St6ckert S3 Roller Pump Module and Console (K950990) * St6ckert SCP Rhythm Module (K042374) * Stdckert S3… | 2006 |
| * | K950990 | Stockert S3 Roller Pump Module Stockert S3 ConsoleSummary page 1…onsole and accessories 3. PREDICATE DEVICES • St6ckert S5 System (K062396) * St6ckert S3 Roller Pump Module and Console (K950990) * St6ckert SCP Rhythm Module (K042374) * Stdckert S3 Cyclic RPM Control (K971520) 4. DEVICE DESCRIPTION… | 1996 |
| * | K042374 | Stockert SCP RhythmSummary page 1…sories 3. PREDICATE DEVICES • St6ckert S5 System (K062396) * St6ckert S3 Roller Pump Module and Console (K950990) * St6ckert SCP Rhythm Module (K042374) * Stdckert S3 Cyclic RPM Control (K971520) 4. DEVICE DESCRIPTION The modified St6ckert S5 System, like the pare… | 2004 |
| * | K971520 | S3 Cyclic RPM ControlSummary page 1…S5 System (K062396) * St6ckert S3 Roller Pump Module and Console (K950990) * St6ckert SCP Rhythm Module (K042374) * Stdckert S3 Cyclic RPM Control (K971520) 4. DEVICE DESCRIPTION The modified St6ckert S5 System, like the parent S5 System, is a modular system consisting… | 1997 |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Jan 28, 2019 | Class III | Z-1119-2020 | Error in labeling | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label… |
| Aug 25, 2016 | Class II | Z-2866-2016 | Employee error | Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply. |
| Dec 4, 2013 | Class II | Z-0856-2014 | Device Design | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. |
| Sep 24, 2013 | Class II | Z-0142-2014 | Software Manufacturing/Software Deployment | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. |
| Sep 19, 2012 | Class II | Z-0274-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could… |
| Sep 19, 2012 | Class II | Z-0275-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could… |
| Sep 19, 2012 | Class II | Z-0272-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could… |
| Sep 19, 2012 | Class II | Z-0271-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could… |
| Sep 19, 2012 | Class II | Z-0273-2013 | Mixed-up of materials/components | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could… |
| Feb 23, 2012 | Not classified | Z-1326-2012 | Nonconforming Material/Component | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob.… |
| Feb 23, 2012 | Not classified | Z-1328-2012 | Nonconforming Material/Component | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob.… |
| Feb 23, 2012 | Not classified | Z-1327-2012 | Nonconforming Material/Component | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob.… |
| Feb 23, 2012 | Not classified | Z-1325-2012 | Nonconforming Material/Component | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob.… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K210130 (Livanova Deutschland, GmbH, 2021) has gone furthest, with 2 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. 2007, 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 modified S5 and the Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071318: Modification to: Stockert S5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071318
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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