# K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi - Pathway: 510(k) (Traditional) - Applicant: Sorin Group Italia S.R.L. - Decided: Feb 29, 2008 after 88 days - Product code: DTZ (Oxygenator, Cardiopulmonary Bypass) - Device class: 2 - Regulation: 21 CFR 870.4350 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K922933 (1992). 10 ancestors in all. 27 later devices descend from it; 2 cite it directly. 3 of 38 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K031223: Synthesis Mimesys Adult Membrane Oxygenator, Dideco S.P.A. (2003). Our reading of the summary gave K031233, FDA’s number for Andiodynamics, Inc. Elvs Procedure Kit (AngioDynamics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SYNTHESIS MIMESYS Adult Membrane Oxygenator with Integrated Arterial…”. - (no number) SYNTHESIS C MIMESYS: Adult Membrane Oxygenator With Integrated Arterial Filter and Softshell Venous Reservoir Mimesys Treated (Phosphorylcholine coating hereinafter called PC coating): named in the summary without a submission number - (no number) SYNTHESIS M MIMESYS Adult Membrane Oxygenator with Integrated Arterial Filter Mimesys treated (Phosphorylcholine coating hereinafter called PC coating): named in the summary without a submission number - (no number) SYNTHESIS R MIMESYS: Hardshell Venous and Cardiotomy Reservoir Mimesys treated (Phosphorylcholine coating hereinafter called PC coating): named in the summary without a submission number ## Most influential descendants - K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 (2009), 21 descendants of its own - K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000 (2009), 12 descendants of its own - K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 descendants of its own - K101153: Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod 70000-Usa, Beq-Hmod 70000-Usa, Hmod (2010), 6 descendants of its own - K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (2013), 4 descendants of its own ## Recalls of this device - Dec 2, 2011 · Not classified · Z-0770-2012: Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro- ## Indications for use Synthesis Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable. Synthesis M Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis M Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis M Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable. Synthesis R Ph.I.S.I.O. has been specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It collects venous blood and it defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. Synthesis R Ph.I.S.I.O. can be used postoperatively for chest drainage. It is suggested not to use Synthesis R Ph.I.S.I.O. for more than 6 hours. Synthesis C Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis C Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis C Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable. Source page: https://510kreport.com/device/K073380 Methodology: https://510kreport.com/methodology