# K221373: Essenz HLM

- Pathway: 510(k) (Traditional)
- Applicant: Livanova Deutschland, GmbH
- Decided: Mar 9, 2023 after 301 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915183 (1992). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210130: Stockert S5 System, Livanova Deutschland, GmbH (2021) Summary page 5.
- K112225: Sorin Centrifugal Pump 5 (CP5), Sorin Group Deutschland GmbH (2011) Summary page 5.
- K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo), Sorin Group Deutschland GmbH (2008) Summary page 5.

## Most influential descendants
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Indications for use
Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Source page: https://510kreport.com/device/K221373
Methodology: https://510kreport.com/methodology