510(k) · Cleared
Recalled · 2010Sorin B-CARE5 for the 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 Nov 5, 2009 as substantially equivalent to K001388 (Dideco, 2000) after an 86-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 5, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001388 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001388 Data Master Perfusion Monitoring SystemDideco · 2000
- This deviceK092463 Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH · 2009
- Descendant · cites it directly · 2 of its ownK103168 B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring…Sorin Group Deutschland GmbH · 2011
- Descendant · 2 generations on · 1 of its ownK202154 B-CaptaLivanova Deutschland, GmbH · 2021
- Descendant · 3 generations on · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K103168B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)Sorin Group Deutschland GmbH · 2011 · cites it directly2descendants
- K202154B-CaptaLivanova Deutschland, GmbH · 2021 · 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 |
|---|---|---|---|---|---|
| −1 | K001388 | Data Master Perfusion Monitoring System | Dideco | 2000 | — |
| 0 (this device) | K092463 | Sorin B-CARE5 for the Stockert S5 System | Sorin Group Deutschland GmbH | 2009 | — |
| +1 | K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) | Sorin Group Deutschland GmbH | 2011 | — |
| +2 | K202154 | B-Capta | Livanova Deutschland, GmbH | 2021 | — |
| +3 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K001388 | Data Master Perfusion Monitoring System | 2000 |
| * | — | S5 System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) | 2011 | 2 |
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-2074-2010 | 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?
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. 2009, 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 B-Care 5 is intended for use as a component part of the Stockert S5 System during cardiopulmonary bypass for procedures up to six hours. B-Care 5 is used exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092463: Sorin B-CARE5 for the 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/K092463
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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