# K092463: Sorin B-CARE5 for the Stockert S5 System

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Nov 5, 2009 after 86 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001388 (2000). 1 ancestor in all.
3 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)
- (no number) S5 System: named in the summary without a submission number

## Most influential descendants
- 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

## Recalls of this device
- Jun 18, 2010 · Not classified · Z-2074-2010: Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder

## Indications for use
The B-Care 5 is intended for use as a component part of the Stockert S5 System during cardiopulmonary bypass for procedures up to six hours. B-Care 5 is used exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit.

Source page: https://510kreport.com/device/K092463
Methodology: https://510kreport.com/methodology