MODIFICATION TO: STOCKERT S5 SYSTEM— 510(k) K071318

Clearance details

Applicant

Sorin Group Deutschland GmbH

Product code

Code DTQ

Device class

Class 2

Regulation

21 CFR 870.4220

Advisory panel

Cardiovascular

Date received

2007-05-10

Decision date

2007-07-06

Decision

Substantially Equivalent

Clearance type

Special

Location

North Attleboro, MA, US

• K232291 — Essenz HLM, Essenz ILBM2023-08-24
• K221895 — Terumo Advanced Perfusion System 12023-04-18
• K221373 — Essenz HLM2023-03-09
• K210130 — Stockert S5 System2021-04-05
• K202125 — Century Perfusion System2021-03-07

• K170460 — Sorin Connect2017-06-08
• K131553 — XTRA2014-03-21
• K140012 — SORIN FLEXTHERM2014-01-31
• K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM2013-07-23
• K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)2011-09-20

Death

123

Malfunction

4,822

Other

1

Total

4,946

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-1119-2020 — LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.Class III·Terminated·LivaNova USA Inc.·20190128
• Z-2866-2016 — St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.Class II·Terminated·Sorin Group USA, Inc.·20160825
• Z-0856-2014 — S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.Class II·Terminated·Sorin Group Deutschland GmbH·20131204
• Z-0142-2014 — S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.Class II·Terminated·Sorin Group Deutschland GmbH·20130924
• Z-0271-2013 — S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0272-2013 — S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0273-2013 — S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0274-2013 — S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0275-2013 — Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071318.