# K220635: Heater-Cooler System 3T

- Pathway: 510(k) (Traditional)
- Applicant: Livanova Deutschland, GmbH
- Decided: Nov 16, 2022 after 257 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- 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 K883603 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191402: Heater-Cooler System 3T, Livanova Deutschland, GmbH (2020) Summary page 5.

## Indications for use
The Heater-Cooler 3T System 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/K220635
Methodology: https://510kreport.com/methodology