# K170460: Sorin Connect

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jun 8, 2017 after 113 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941811 (1994). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131816: Sorin Connect Data Management System, Sorin Group Deutschland GmbH (2013) Summary page 4.

## Most influential descendants
- K212003: ESSENZ Patient Monitor (2021), 0 descendants of its own

## Indications for use
The device is a modularly structured program package that is exclusively used with Sorin/Stockert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

Source page: https://510kreport.com/device/K170460
Methodology: https://510kreport.com/methodology