# K001021: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant Hollow Fibre Oxygenator, Model D902

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Apr 25, 2000 after 26 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir (2007), 12 descendants of its own
- K103191: Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating (2011), 6 descendants of its own
- K100278: Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod 30000-Usa, Beq-Hmod 30000-Usa (2010), 6 descendants of its own
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (2013), 4 descendants of its own
- K150267: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (2015), 2 descendants of its own

Source page: https://510kreport.com/device/K001021
Methodology: https://510kreport.com/methodology