# K191402: Heater-Cooler System 3T

- Pathway: 510(k) (Traditional)
- Applicant: Livanova Deutschland, GmbH
- Decided: Feb 25, 2020 after 277 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- 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: 3 generations back to K883603 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052601: Stockert Heater-Cooler System 3T, Sorin Group Deutschland GmbH (2006) Summary page 4.

## Most influential descendants
- K220635: Heater-Cooler System 3T (2022), 0 descendants of its own

## Recalls of this device
- Aug 3, 2023 · Class II · Z-0073-2024: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

## Indications for use
The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Source page: https://510kreport.com/device/K191402
Methodology: https://510kreport.com/methodology