510(k) · Cleared
Recalled · 2012Stockert 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 Jun 2, 2006 after a 147-day review. The FDA summary names its predicate without a number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 20 times.
- Decided
- Jun 2, 2006
- Review
- 147 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 20
- Predicates
- 0
3 later devices descend from it, 3 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK060053 Stockert S5 SystemSorin Group Deutschland GmbH · 2006
- Descendant · cites it directly · 0 of its ownK202125 Century Perfusion SystemCentury Hlm, LLC · 2021
- Descendant · cites it directly · 0 of its ownK190282 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH…Spectrum Medical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK173834 Quantum Pump ConsoleSpectrum Medical, Ltd. · 2018 · Recalled (Class I)
Class I recalls in this family
- K173834 Quantum Pump Consolecites it directly · 2018
Most influential descendants
Showing 3 of 3 · See all- K202125Century Perfusion SystemCentury Hlm, LLC · 2021 · cites it directly0descendants
- K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical, Ltd. · 2019 · cites it directly0descendants
- K173834Quantum Pump ConsoleSpectrum Medical, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060053 | Stockert S5 System | Sorin Group Deutschland GmbH | 2006 | — |
| +1 | K202125 | Century Perfusion System | Century Hlm, LLC | 2021 | — |
| +1 | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical, Ltd. | 2019 | — |
| +1 | K173834 | Quantum Pump Console | Spectrum Medical, Ltd. | 2018 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 1 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Stockert S3 System Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2012 | Not classified | Z-1149-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1155-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1151-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1158-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1157-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1152-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1153-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1150-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1154-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Feb 16, 2012 | Not classified | Z-1156-2012 | Mixed-up of materials/components | Touch screen may be unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0965-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0957-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0958-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0963-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0964-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0956-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0959-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0960-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0962-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
| Nov 12, 2010 | Not classified | Z-0961-2011 | Device Design | Touch screen may become unresponsive, inhibiting user input. |
The 5 latest of 20 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173834Quantum Pump ConsoleSpectrum Medical, Ltd. · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K202125 (Century Hlm, LLC, 2021) has gone furthest, with 0 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 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/K060053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060053: Stockert S5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060053
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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