# K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Feb 26, 2002 after 22 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: 2 generations back to K922933 (1992). 4 ancestors in all.
72 later devices descend from it; 6 cite it directly.
3 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980600: D903 Avant Adult Hollow Fiber Oxygenator, Dideco S.P.A. (1998) Summary page 1.
- K010478: Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag, with Biocompatable Treatment Sur, Dideco (2001) Summary page 1.
- K004001: Monolyth Mimesys Hollow Fiber Oxygenator, Dideco (2001) Summary page 1.

## Most influential descendants
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy (2002), 35 descendants of its own
- K031223: Synthesis Mimesys Adult Membrane Oxygenator (2003), 32 descendants of its own
- K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating (2004), 28 descendants of its own
- 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

## Indications for use
The Dideco D 903 Avant 2 Ph.1.S.1.0. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient’s veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

Source page: https://510kreport.com/device/K020351
Methodology: https://510kreport.com/methodology