# K991737: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant/Newborn Hollow Fiber Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Dideco S.P.A.
- Decided: Feb 17, 2000 after 272 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061031: D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir W (2006), 13 descendants of its own
- 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

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-2469-2008: Under certain conditions, venous reservoir on oxygenator may allow air into the system.

## Indications for use
The Dideco Lilliput Ph.I.S.I.0.Membrane Oxygenator is intended for use in ilufancs welghing not more than 8 Kg (17.6 1b.) who underyo cardilopulmondry bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide rewmoval from venous blood. The integrated heat exchanger providea hland temperature cantral and allaws the use of hynpothermia ar aids in the waintenance of normotherwia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The Lilliput Ph.I.S.I.0. should not be used longer than 6 hours. Contact with blood for longer periods is not advised,

Source page: https://510kreport.com/device/K991737
Methodology: https://510kreport.com/methodology