# K231652: D100 Kids; D101 Kids

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 16, 2023 after 163 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: 3 generations back to K991737 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir, Sorin Group Italia S.R.L. (2007) Summary page 4.

## Cited in the summary but kept off the family tree
- K060103: Albert Browne LTD. Verify Steam Value Indicators, Albert Browne, Ltd. (2006). Our reading of the summary gave K060103, FDA’s number for Albert Browne LTD. Verify Steam Value Indicators (Albert Browne, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “D100 KIDS”. Kept off the family tree. Summary page 4.

## Indications for use
The D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less. The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less

Source page: https://510kreport.com/device/K231652
Methodology: https://510kreport.com/methodology