# K031223: Synthesis Mimesys Adult Membrane Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: May 2, 2003 after 14 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922933 (1992). 9 ancestors in all.
32 later devices descend from it; 3 cite it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy, Dideco S.P.A. (2002) Summary page 3.
- K990103: Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and 1200 Softshe, Sorin Biomedical, Inc. (1999) Summary page 1.
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator, Dideco S.P.A. (2002)
- K004001: Monolyth Mimesys Hollow Fiber Oxygenator, Dideco (2001) Summary page 1.

## Most influential descendants
- K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi (2008), 27 descendants of its own
- 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

## Indications for use
Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the llungs (transfer of oxygen and removal of carbon dioxide), to control the artendvenous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis hdimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

Source page: https://510kreport.com/device/K031223
Methodology: https://510kreport.com/methodology