# K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Jul 9, 2003 after 8 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- 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). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030154: Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Dideco S.P.A. (2003)
- K031223: Synthesis Mimesys Adult Membrane Oxygenator, Dideco S.P.A. (2003) Summary page 1.
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy, Dideco S.P.A. (2002) Summary page 1.
- K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700, Cobe Cardiovascular, Inc. (2003) Summary page 1.

## Most influential descendants
- K050890: Ecc.O System (2005), 1 descendant of its own
- K082412: Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160 (2008), 0 descendants of its own

## Recalls of this device
- Dec 2, 2011 · Not classified · Z-0769-2012: 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
Ideal Mirnesys is intended to be used in adult surgical procedures requiring extracorporealgas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours, Contact with Mood for longer periods is inadvisable. Ideal Mirnesys is intended for use with the Stockert Centrifugal Pump Console.

Source page: https://510kreport.com/device/K032040
Methodology: https://510kreport.com/methodology