# K030154: Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator

- Pathway: 510(k) (Abbreviated)
- Applicant: Dideco S.P.A.
- Decided: Mar 31, 2003 after 74 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 13 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 1.
- K011835: Cobe Revolution, Cobe Cardiovascular, Inc. (2002) Summary page 1.

## Most influential descendants
- K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator (2003), 2 descendants of its own
- 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

## Indications for use
Ideal is intended to be used in surgical procedures requiring extracorporeal gas exchange support. Ideal is intended for use in operations on adult patients. Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal is intended for use with the Stockert Centrifugal Pump Console.

Source page: https://510kreport.com/device/K030154
Methodology: https://510kreport.com/methodology