# K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir

- Pathway: 510(k) (Abbreviated)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 29, 2007 after 91 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 K991737 (2000). 5 ancestors in all.
12 later devices descend from it; 5 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001021: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant Hollow Fibre Oxygenator, Model D902, Dideco S.P.A. (2000) Summary page 1.
- K061031: D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir W, Sorin Group Italia S.R.L. (2006) Summary page 1.

## Most influential descendants
- 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
- K203424: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1,  Quantum Perfusion Blood Oxygenator ECC VT160-E2 (2021), 1 descendant of its own

## Indications for use
The D101 KIDS Infant Hollow Fiber Membrane Oxygenator is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 2.5 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 D101 KIDS should not be used longer than 6 hours. Contact with blood for longer periods is not advised. The D101 KIDS Infant Hollow Fiber Membrane Oxygenator is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 2.5 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 D101 KIDS should not be used longer than 6 hours. Contact with blood for longer periods is not advised. D121 KIDS HVR has been specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It collects venous blood and it defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. The D121 KIDS HVR should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K072091
Methodology: https://510kreport.com/methodology