# K140012: Sorin Flextherm

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 31, 2014 after 29 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: 3 generations back to K883603 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.

## Indications for use
The Sorin Flexmennm Heater-Coaler System is used with~ a Stdckert S3 heart-lung machine and or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Source page: https://510kreport.com/device/K140012
Methodology: https://510kreport.com/methodology