# K052601: Stockert Heater-Cooler System 3T

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jun 6, 2006 after 258 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883603 (1988). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811742: Hemotherm Model 400, Cincinnati Sub-Zero (1981) Summary page 1.
- K001520: Alpha Omega Dual Cooler-Heater, Alpha Omega, Inc. (2000) Summary page 1.
- K031544: Heater Cooler Unit, Model Hcu 30, Jostra AB (2003) Summary page 1.

## Most influential descendants
- K191402: Heater-Cooler System 3T (2020), 1 descendant of its own
- K220635: Heater-Cooler System 3T (2022), 0 descendants of its own
- K212657: Quantum Heater-Cooler (2022), 0 descendants of its own
- K140012: Sorin Flextherm (2014), 0 descendants of its own

## Recalls of this device
- Feb 24, 2020 · Class II · Z-1498-2020: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
- Nov 1, 2018 · Class II · Z-0220-2020: The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In
- Sep 14, 2018 · Class II · Z-1099-2019: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
- Apr 20, 2018 · Class II · Z-1901-2018: Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visi
- Jun 30, 2017 · Class II · Z-2776-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 30, 2017 · Class II · Z-2775-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 30, 2017 · Class II · Z-2773-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 30, 2017 · Class II · Z-2772-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 30, 2017 · Class II · Z-2771-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 30, 2017 · Class II · Z-2774-2017: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Jun 15, 2015 · Class II · Z-2081-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Jun 15, 2015 · Class II · Z-2079-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Jun 15, 2015 · Class II · Z-2078-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Jun 15, 2015 · Class II · Z-2080-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Jun 15, 2015 · Class II · Z-2076-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Jun 15, 2015 · Class II · Z-2077-2015: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
- Aug 1, 2014 · Class II · Z-0682-2017: On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).
- Aug 15, 2012 · Class II · Z-1186-2016: On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the

## Indications for use
The Stbckert Heater-Cooler System 3T is used with a St6ckert 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/K052601
Methodology: https://510kreport.com/methodology