# K202154: B-Capta

- Pathway: 510(k) (Traditional)
- Applicant: Livanova Deutschland, GmbH
- Decided: Apr 1, 2021 after 241 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
Longest line of descent: 3 generations back to K001388 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K001388: Data Master Perfusion Monitoring System, Dideco (2000) Summary page 5.
- K103168: B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head), Sorin Group Deutschland GmbH (2011) Summary page 5.

## Most influential descendants
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Indications for use
B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

Source page: https://510kreport.com/device/K202154
Methodology: https://510kreport.com/methodology