SORIN CENTRIFUGAL PUMP 5 (CP5)— 510(k) K112225

Name: FDA 510(k) clearance K112225
Creator: U.S. Food and Drug Administration
Published: 2011-09-20

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K112225 for SORIN CENTRIFUGAL PUMP 5 (CP5), Substantially Equivalent on 2011-09-20. Applicant: Sorin Group Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DWA
Device class: Class 2
Regulation: 21 CFR 870.4380
Advisory panel: Cardiovascular
Date received: 2011-08-03
Decision date: 2011-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWA

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More clearances from Sorin Group Deutschland GmbH

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K170460 — Sorin Connect2017-06-08
K131553 — XTRA2014-03-21
K140012 — SORIN FLEXTHERM2014-01-31
K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM2013-07-23
K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)2011-01-20

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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 →

Recalls naming K112225

K-number listed on FDA's recall record

Z-0787-2022 — Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.Class III·Terminated·LivaNova Deutschland GmbH·20211217
Z-0401-2018 — CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.Class II·Terminated·Sorin Group Deutschland GmbH·20171030
Z-0857-2014 — CP5 centrifugal pump system 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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112225.

Data sourced from openFDA. This site is unofficial and independent of the FDA.