# K050890: Ecc.O System

- Pathway: 510(k) (Special)
- Applicant: Dideco S.R.L.
- Decided: May 5, 2005 after 27 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: 6 generations back to K922933 (1992). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, Dideco S.R.L. (2005) Summary page 1.
- K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Dideco S.P.A. (2003) Summary page 1.

## Most influential descendants
- 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
The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

Source page: https://510kreport.com/device/K050890
Methodology: https://510kreport.com/methodology