# K232291: Essenz HLM, Essenz ILBM

- Pathway: 510(k) (Special)
- Applicant: Livanova Deutschland, GmbH
- Decided: Aug 24, 2023 after 23 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: 5 generations back to K915183 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221373: Essenz HLM, Livanova Deutschland, GmbH (2023) Summary page 3.
- K202154: B-Capta, Livanova Deutschland, GmbH (2021) Summary page 6.

## Recalls of this device
- Oct 18, 2024 · Class II · Z-0571-2025: Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may oc

## Indications for use
Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

Source page: https://510kreport.com/device/K232291
Methodology: https://510kreport.com/methodology