STOCKERT HEATER-COOLER SYSTEM 3T— 510(k) K052601

Clearance details

Applicant

Sorin Group Deutschland GmbH

Product code

Code DWC

Device class

Class 2

Regulation

21 CFR 870.4250

Advisory panel

Cardiovascular

Date received

2005-09-21

Decision date

2006-06-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Attleboro, MA, US

• K220635 — Heater-Cooler System 3T2022-11-16
• K212657 — Quantum Heater-Cooler2022-05-06
• K191402 — Heater-Cooler System 3T2020-02-25
• K140012 — SORIN FLEXTHERM2014-01-31
• K130300 — HEATER-COOLER UNIT HCU 402013-07-01

• K170460 — Sorin Connect2017-06-08
• K131553 — XTRA2014-03-21
• K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM2013-07-23
• K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)2011-09-20
• K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)2011-01-20

Death

124

Injury

233

Malfunction

3,727

Total

4,084

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1498-2020 — LivaNova Heater-Cooler System 3T - Product Usage: 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.Class II·Terminated·LivaNova USA Inc.·20200224
• Z-0220-2020 — SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters. " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger, temperatures ranging from 2 degrees Celsius to 10 degrees Celsius (cooling tank) and/or from 15 degrees Celsius to 41 degrees Celsius (heating tank). If required, the circuits for the patient and the circuit for cardioplegia can be switched off separately, in order to increase the activated functional group s heating and/or cooling performance. Product Usage: The Stockert Heater-Cooler System 3T is intended for use with a Stockert/Sorin S3/S5/C5 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.Class II·Terminated·LivaNova USA Inc.·20181101
• Z-1099-2019 — SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 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.Class II·Terminated·LivaNova USA Inc.·20180914
• Z-1901-2018 — Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 HzClass II·Terminated·LivaNova USA·20180420
• Z-2771-2017 — STOCKERT Heater-Cooler System 3T, 230 VClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2772-2017 — STOCKERT Heater-Cooler System 3T, 240V/60 HzClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2773-2017 — STOCKERT Heater-Cooler System 3T, 208V/60 HzClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2774-2017 — STOCKERT Heater-Cooler System 3T, 127V/60 HzClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2775-2017 — STOCKERT Heater-Cooler System 3T, 120V/60 HzClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2776-2017 — STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 HzClass II·Terminated·Sorin Group USA, Inc.·20170630
• Z-2076-2015 — Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-2077-2015 — Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-2078-2015 — Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-2079-2015 — Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-2080-2015 — Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-2081-2015 — Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.Class II·Terminated·Sorin Group USA, Inc.·20150615
• Z-0682-2017 — ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hoursClass II·Terminated·Sorin Group USA, Inc.·20140801
• Z-1186-2016 — Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259Class II·Terminated·Sorin Group USA, Inc.·20120815

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052601.