510(k) · Cleared
ClearedB-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Jan 6, 2011 as substantially equivalent to K001388 (Dideco, 2000) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jan 6, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001388 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001388 Data Master Perfusion Monitoring SystemDideco · 2000
- 1 generation backK092463 Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH · 2009 · Recalled
- This deviceK103168 B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring…Sorin Group Deutschland GmbH · 2011
- Descendant · cites it directly · 1 of its ownK202154 B-CaptaLivanova Deutschland, GmbH · 2021
- 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 |
|---|---|---|---|---|---|
| −2 | K001388 | Data Master Perfusion Monitoring System | Dideco | 2000 | — |
| −1 | K092463 | Sorin B-CARE5 for the Stockert S5 System | Sorin Group Deutschland GmbH | 2009 | 1 |
| 0 (this device) | K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) | Sorin Group Deutschland GmbH | 2011 | — |
| +1 | K202154 | B-Capta | Livanova Deutschland, GmbH | 2021 | — |
| +2 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DRY? 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 DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 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 SystemSummary page 1…Cardiopulmonary bypass, on-line blood gas monitor (21 CFR 870.4330; Product code: DRY) 3. PREDICATE DEVICE/s " Dideco Data Master, K001388 " Sorin B-Care 5 (Addition of an Optional Modular Accessory to the Sttickert S5 System), K092463) 4. DEVICE DESCRIPTION… | 2000 |
| * | K092463 | Sorin B-CARE5 for the Stockert S5 SystemSummary page 1…duct code: DRY) 3. PREDICATE DEVICE/s " Dideco Data Master, K001388 " Sorin B-Care 5 (Addition of an Optional Modular Accessory to the Sttickert S5 System), K092463) 4. DEVICE DESCRIPTION * Physical description The Sorin B-Care 5 described in this 5 10(k) Premarket Notification is i… | 2009 |
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 |
|---|---|---|---|
| K202154 | B-Capta | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K202154 (Livanova Deutschland, GmbH, 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K001388.
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B-Care5 is intended for use as a component part of or optional accessory to the Stockert S5 system (or any compatible system using the S5 firmware versions of 3.0 or greater), during cardiopulmonary bypass for procedures up to six hours. The B-Care5 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/K103168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103168: B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103168
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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