# K212003: ESSENZ Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Livanova Deutschland, GmbH
- Decided: Nov 10, 2021 after 135 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: 9 generations back to K941811 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170460: Sorin Connect, Sorin Group Deutschland GmbH (2017) Summary page 5.

## Indications for use
ESSENZ Patient Monitor is a modularly structured program package that is exclusively used with LivaNova 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/K212003
Methodology: https://510kreport.com/methodology