# K001388: Data Master Perfusion Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Dideco
- Decided: Jul 28, 2000 after 87 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092463: Sorin B-CARE5 for the Stockert S5 System (2009), 3 descendants of its own
- K103168: B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) (2011), 2 descendants of its own
- K202154: B-Capta (2021), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K001388
Methodology: https://510kreport.com/methodology