# K131816: Sorin Connect Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jul 23, 2013 after 33 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: 7 generations back to K941811 (1994). 18 ancestors in all.
2 later devices descend 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)
- K100272: Intellivue Clinical Information Portfolio, Philips Medical Systems (2010) Summary page 1.
- K113214: Tlink Data Management System (DMS), Terumo Cardiovascular Systems Corp. (2012) Summary page 1.

## Most influential descendants
- K170460: Sorin Connect (2017), 1 descendant of its own
- K212003: ESSENZ Patient Monitor (2021), 0 descendants of its own

## Indications for use
Sorin CONNECT is a modularly structured program package that is exclusively used With Sorin/Stöckert 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/K131816
Methodology: https://510kreport.com/methodology