# K061031: D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir W

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 2, 2006 after 49 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: 1 generation back to K991737 (2000). 3 ancestors in all.
13 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991737: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant/Newborn Hollow Fiber Oxygenator, Dideco S.P.A. (2000) 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.
- K001602: Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (PH. I.S.I.O.), Dideco S.P.A. (2000)

## 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

## Indications for use
The D 100 L001 Ph.l.S.I.O. Newborn-Hollow Fiber Membrane Oxygenator with Phosphorilcholine Coating is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned 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 is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation, to always assure the proper oxygenation capability of the device. The D 100 L001 Ph.I.S.I.O. should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K061031
Methodology: https://510kreport.com/methodology