510(k) · Cleared
ClearedData Master Perfusion Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Jul 28, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 28, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK001388 Data Master Perfusion Monitoring SystemDideco · 2000
- Descendant · cites it directly · 3 of its ownK092463 Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH · 2009 · Recalled
- 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 · 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 4 of 4 · See all- K092463Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH · 2009 · cites it directly3descendants
- 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 · cites it directly1descendant
- K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001388 | Data Master Perfusion Monitoring System | Dideco | 2000 | — |
| +1 | K092463 | Sorin B-CARE5 for the Stockert S5 System | Sorin Group Deutschland GmbH | 2009 | 1 |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092463 (Sorin Group Deutschland GmbH, 2009) has gone furthest, with 3 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K001388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001388: Data Master Perfusion Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001388
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026