Sorin Connect Data Management System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K131816 ↗

FDA Product Code

DXJ

Device Class

Class II

Regulation

21 CFR Part 870.2450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

See all devices from Sorin Group Deutschland GmbH →

• What is the primary purpose of the Sorin Connect Data Management System in a clinical setting?

  The Sorin Connect Data Management System is designed to capture, process, and evaluate real-time hemodynamic data during cardiopulmonary bypass procedures. It interfaces exclusively with Sorin/Stockert heart-lung machines to record critical perfusion parameters, enabling clinicians to make informed decisions during cardiovascular surgery.

• Is the Sorin Connect Data Management System reusable or single-use, and what are its sterility requirements?

  The Sorin Connect Data Management System is supplied as a non-sterile, reusable software package. Since it is a modular program, it does not require sterilization and is intended for repeated use in clinical environments.

• How is this device regulated, and what classification does it fall under?

  The Sorin Connect Data Management System holds FDA 510(k) clearance (K131816) under the Cardiovascular advisory committee classification. It is classified as a Class II device (per OpenFDA data) and was determined to be substantially equivalent to a predicate device.

• Does this system require any special storage conditions, such as temperature or MRI safety considerations?

  The regulatory submission does not specify any MRI safety requirements or size-specific storage conditions for the Sorin Connect Data Management System. However, as a reusable software-based system, it should be stored in a secure, controlled environment to prevent unauthorized access or data corruption.