Xtra

FDA 510(k) K112245 · Sorin Group Italia S.R.L.

Substantially Equivalent

510(k) numberK112245

Submission

Device name
Xtra
Applicant
Sorin Group Italia S.R.L.
Waltham, MA, US
Received
August 4, 2011
Decision date
September 6, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAC – Apparatus, Autotransfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5830
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code CAC

510(k)DeviceApplicantDecision
K241236XTRA Collection sets; XTRA Sequestration set XCAC · Special Sorin Group Italia S.R.L.08/16/2024SE
K240426Aventus Clot Management SystemCAC · Traditional Inquis Medical05/14/2024SE
K240584XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special Sorin Group Italia S.R.L.04/29/2024SE
K231782FlowSaver Blood Return System (80-101)CAC · Special Inari Medical, Inc.07/14/2023SE
K221483FlowSaver Blood Return SystemCAC · Traditional Inari Medical, Inc.02/17/2023SE
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional Haemonetics Corporation11/15/2022SE
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional Atrium Medical Corporation09/03/2021SE
K210862Hemafuse SystemCAC · Traditional Sisu Global Health07/29/2021SE
K210176FlowSaver Blood FilterCAC · Traditional Inari Medical07/22/2021SE
K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special Fresenius Kabi AG02/11/2021SE

More from Fresenius Kabi AG

510(k)DeviceDecision
K253671Dual Stage Venous CannulaeDWF · Traditional 01/30/2026SE
K251783Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional 12/22/2025SE
K253616ProtekDilate Vascular Access KitDRE · Special 12/19/2025SE
K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special 06/27/2025SE
K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special 05/30/2025SE
K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…KDI · Traditional 04/25/2025SE
K242953KIDS Arterial FiltersDTM · Special 12/20/2024SE
K242092MICRO Arterial FiltersDTM · Special 11/18/2024SE
K241236XTRA Collection sets; XTRA Sequestration set XCAC · Special 08/16/2024SE
K240584XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special 04/29/2024SE

Questions and answers

When was Xtra cleared by the FDA?

Xtra (K112245) received a 510(k) decision of Substantially Equivalent on September 6, 2011, 33 days after the submission was received.

What is the product code of K112245?

The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.