# K103168: B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 6, 2011 after 71 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: 2 generations back to K001388 (2000). 2 ancestors in all.
2 later devices descend 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 1.
- K092463: Sorin B-CARE5 for the Stockert S5 System, Sorin Group Deutschland GmbH (2009) Summary page 1.

## Most influential descendants
- K202154: B-Capta (2021), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103168
Methodology: https://510kreport.com/methodology